Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This is a multicenter study. Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes prior to registration to confirm eligibility and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. The primary and secondary objectives of the study are described below.
Primary Objective:
- To determine the false negative rate for sentinel lymph node (SLN) surgery. Among the patients who have at least one sentinel lymph node identified and removed, false negative rate is defined as the number of patients declared to have no evidence of cancer in the SLN and are found to have at least one positive lymph node in the ALND divided by the total number of patients with at least one positive axillary lymph node by ALND.
Secondary Objectives:
-
To determine how the axillary ultrasound status of the patient upon completion of preoperative chemotherapy (evidence of residual lymphadenopathy on the ultrasound examination versus no evidence of lymphadenopathy in the ultrasound examination) affects the false negative rate of SLN and how sonographic findings correlate with residual disease on final pathology.
-
To determine the node status of patients after preoperative chemotherapy. Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND. Patients will be classified as node negative if all nodes examined by SLN and ALND were negative.
-
To determine whether the false-negative rate for SLN surgery after preoperative chemotherapy is related to the extent of residual cancer burden (RCB) overall, or separately in the breast or regional nodal basin.
-
To evaluate pathological complete response (pCR) rates (defined as no invasive disease in breast or lymph nodes) and disease-free survival (DFS) rates in node-positive patients receiving preoperative chemotherapy.
After completion of surgery, patients will visit the office for follow-up exams at 1-2 weeks then patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years. The study closed to accrual and treatment on 5/29/12.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Study cohort Patients who plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. |
Drug: systemic chemotherapy
Procedure: axillary lymph node dissection
Procedure: neoadjuvant therapy
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Procedure: ultrasound imaging
|
Outcome Measures
Primary Outcome Measures
- False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN1 Breast Cancer [cN1 Cohort] [At time of surgery]
False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN1 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. A 2-sided Bayesian credible interval (BCI) for the true FNR was constructed.
Secondary Outcome Measures
- False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN2 Breast Cancer [cN2 Cohort] [At time of surgery]
False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN2 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. An interval estimate of the SLN false negative rate will be constructed using the Duffy-Santner approach.
- False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC) [At the time of surgery]
False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy in women with normal AUS and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100.
- Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND) [At time of surgery]
Node status of patients after preoperative chemotherapy, as measured by the total number of positive nodes (SLN+ALND). Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND.
- Pathologic Complete Nodal Response (pCR) Rate [At the time of surgery]
Pathologic complete nodal response (pCR) rate (percentage) wherein a nodal pCR is pathologically node-negative (pN0) on the basis of SLN surgery and ALND. A 95% binomial confidence interval was constructed for the pCR rate.
- Residual Cancer Burden Class [At time of surgery]
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The calculated RCB index value can also be categorized as one of four RCB classes. The number of patients classified in the four RCB classes along with the number of patients missing this data by cohort are reported below. RCB of 0 represents a path complete response while increasing levels (I, then II, then III) indicate an increase in the 'amount' of residual disease remaining.
Other Outcome Measures
- Disease-Free Survival [Up to 10 years]
Eligibility Criteria
Criteria
Eligibility Criteria:
-
≥ 18 years old
-
ECOG/Zubrod Performance Status 0-1
-
Female. Note: Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
-
Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer).
-
FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy.
-
Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients enrolling on studies involving preoperative chemotherapy (through cooperative groups or institutional studies) may be eligible for this study, provided sentinel node surgery prior to preoperative chemotherapy was not required in the other studies.
-
No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
-
No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | United States | 36688 |
2 | Providence Cancer Center | Anchorage | Alaska | United States | 99508 |
3 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
4 | East Bay Radiation Oncology Center | Castro Valley | California | United States | 94546 |
5 | Valley Medical Oncology Consultants - Castro Valley | Castro Valley | California | United States | 94546 |
6 | Cancer Care Center at John Muir Health - Concord Campus | Concord | California | United States | 94524-4110 |
7 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
8 | Valley Medical Oncology | Fremont | California | United States | 94538 |
9 | Todd Cancer Institute at Long Beach Memorial Medical Center | Long Beach | California | United States | 90806 |
10 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90089-9181 |
11 | Contra Costa Regional Medical Center | Martinez | California | United States | 94553-3156 |
12 | Community Hospital of the Monterey Peninsula Comprehensive Cancer Center | Monterey | California | United States | 93940 |
13 | Camino Medical Group - Treatment Center | Mountain View | California | United States | 94040 |
14 | El Camino Hospital Cancer Center | Mountain View | California | United States | 94040 |
15 | Highland General Hospital | Oakland | California | United States | 94602 |
16 | Bay Area Breast Surgeons, Incorporated | Oakland | California | United States | 94609 |
17 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609 |
18 | Larry G Strieff MD Medical Corporation | Oakland | California | United States | 94609 |
19 | Tom K Lee, Incorporated | Oakland | California | United States | 94609 |
20 | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | United States | 92868 |
21 | Palo Alto Medical Foundation | Palo Alto | California | United States | 94301 |
22 | Sharp Memorial Hospital Cancer Center | San Diego | California | United States | 92123 |
23 | Doctors Medical Center - San Pablo Campus | San Pablo | California | United States | 94806 |
24 | Stanford Cancer Center | Stanford | California | United States | 94305-5824 |
25 | John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek | California | United States | 94598 |
26 | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado | United States | 80045 |
27 | Bridgeport Hospital | Bridgeport | Connecticut | United States | 06610 |
28 | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
29 | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
30 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
31 | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | United States | 33458 |
32 | CCOP - Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
33 | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | United States | 33136 |
34 | Robert and Carol Weissman Cancer Center at Martin Memorial | Stuart | Florida | United States | 34994 |
35 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
36 | Northside Hospital Cancer Center | Atlanta | Georgia | United States | 30342-1611 |
37 | WellStar Cobb Hospital | Austell | Georgia | United States | 30106 |
38 | John B. Amos Cancer Center | Columbus | Georgia | United States | 31904 |
39 | Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | United States | 30033 |
40 | Piedmont Fayette Hospital | Fayetteville | Georgia | United States | 30214 |
41 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
42 | Gwinnett Medical Center | Lawrenceville | Georgia | United States | 30045 |
43 | Medical Center of Central Georgia | Macon | Georgia | United States | 31208 |
44 | Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta | Georgia | United States | 30060 |
45 | Southern Regional Medical Center | Riverdale | Georgia | United States | 30274-2600 |
46 | Harbin Clinic Cancer Center - Medical Oncology | Rome | Georgia | United States | 30165 |
47 | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | United States | 62002 |
48 | Illinois CancerCare - Bloomington | Bloomington | Illinois | United States | 61701 |
49 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
50 | Graham Hospital | Canton | Illinois | United States | 61520 |
51 | Illinois CancerCare - Canton | Canton | Illinois | United States | 61520 |
52 | Illinois CancerCare - Carthage | Carthage | Illinois | United States | 62321 |
53 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
54 | John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | United States | 60612-3785 |
55 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
56 | Illinois CancerCare - Eureka | Eureka | Illinois | United States | 61530 |
57 | Evanston Hospital | Evanston | Illinois | United States | 60201-1781 |
58 | Galesburg Clinic, PC | Galesburg | Illinois | United States | 61401 |
59 | Illinois CancerCare - Galesburg | Galesburg | Illinois | United States | 61401 |
60 | Illinois CancerCare - Havana | Havana | Illinois | United States | 62644 |
61 | Mason District Hospital | Havana | Illinois | United States | 62644 |
62 | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
63 | Illinois CancerCare - Macomb | Macomb | Illinois | United States | 61455 |
64 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
65 | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
66 | Illinois CancerCare - Monmouth | Monmouth | Illinois | United States | 61462 |
67 | OSF Holy Family Medical Center | Monmouth | Illinois | United States | 61462 |
68 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
69 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
70 | Community Cancer Center | Normal | Illinois | United States | 61761 |
71 | Illinois CancerCare - Community Cancer Center | Normal | Illinois | United States | 61761 |
72 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
73 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
74 | Illinois CancerCare - Pekin | Pekin | Illinois | United States | 61603 |
75 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
76 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
77 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
78 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
79 | Illinois CancerCare - Peru | Peru | Illinois | United States | 61354 |
80 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
81 | Illinois CancerCare - Princeton | Princeton | Illinois | United States | 61356 |
82 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
83 | Illinois CancerCare - Spring Valley | Spring Valley | Illinois | United States | 61362 |
84 | Clarian West Medical Center | Avon | Indiana | United States | 46123 |
85 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
86 | Clarian North Medical Center | Carmel | Indiana | United States | 46032 |
87 | Elkhart Clinic, LLC | Elkhart | Indiana | United States | 46514-2098 |
88 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
89 | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202-5289 |
90 | William N. Wishard Memorial Hospital | Indianapolis | Indiana | United States | 46202 |
91 | Howard Community Hospital | Kokomo | Indiana | United States | 46904 |
92 | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | United States | 46350 |
93 | Saint Joseph Regional Medical Center | Mishawaka | Indiana | United States | 46545-1470 |
94 | Reid Hospital & Health Care Services | Richmond | Indiana | United States | 47374 |
95 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
96 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
97 | Michiana Hematology-Oncology, PC - South Bend | South Bend | Indiana | United States | 46601 |
98 | Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | United States | 50325 |
99 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
100 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
101 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
102 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
103 | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
104 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
105 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
106 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
107 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
108 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
109 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
110 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
111 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
112 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
113 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
114 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
115 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
116 | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | United States | 67905 |
117 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
118 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
119 | Saint Luke's Hospital - South | Overland Park | Kansas | United States | 66213 |
120 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
121 | CCOP - Kansas City | Prairie Village | Kansas | United States | 66208 |
122 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
123 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67401 |
124 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
125 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67208 |
126 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
127 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
128 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
129 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
130 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
131 | St. Elizabeth Medical Center | Edgewood | Kentucky | United States | 41017 |
132 | Central Baptist Hospital | Lexington | Kentucky | United States | 40503-9985 |
133 | Maine Medical Center - Bramhall Campus | Portland | Maine | United States | 04102 |
134 | DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland | United States | 21401 |
135 | Mercy Medical Center | Baltimore | Maryland | United States | 21202 |
136 | Peninsula Regional Medical Center | Salisbury | Maryland | United States | 21801 |
137 | Holy Cross Hospital | Silver Spring | Maryland | United States | 20910 |
138 | Cancer Institute at St. Joseph Medical Center | Towson | Maryland | United States | 21204 |
139 | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
140 | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | United States | 49221 |
141 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0942 |
142 | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | United States | 49017 |
143 | Mecosta County Medical Center | Big Rapids | Michigan | United States | 49307 |
144 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
145 | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
146 | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | United States | 49431 |
147 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
148 | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | United States | 49503 |
149 | Dickinson County Healthcare System | Iron Mountain | Michigan | United States | 49801 |
150 | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | United States | 48144 |
151 | Community Cancer Center of Monroe | Monroe | Michigan | United States | 48162 |
152 | Mercy Memorial Hospital - Monroe | Monroe | Michigan | United States | 48162 |
153 | Mercy General Health Partners | Muskegon | Michigan | United States | 49443 |
154 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
155 | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | United States | 49085 |
156 | Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan | United States | 49085 |
157 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
158 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
159 | Alexandria | Minnesota | United States | 56308 | |
160 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
161 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
162 | CentraCare Clinic - River Campus | Saint Cloud | Minnesota | United States | 56303 |
163 | Coborn Cancer Center | Saint Cloud | Minnesota | United States | 56303 |
164 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
165 | Saint Luke's Hospital | Chesterfield | Missouri | United States | 63017 |
166 | St. John's Regional Medical Center | Joplin | Missouri | United States | 64804 |
167 | Truman Medical Center - Hospital Hill | Kansas City | Missouri | United States | 64108 |
168 | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | United States | 64111 |
169 | St. Joseph Medical Center | Kansas City | Missouri | United States | 64114 |
170 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
171 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
172 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
173 | Liberty Hospital | Liberty | Missouri | United States | 64068 |
174 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
175 | Midwest Hematology Oncology Group, Incorporated | Saint Louis | Missouri | United States | 63109 |
176 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
177 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
178 | David C. Pratt Cancer Center at St. John's Mercy | Saint Louis | Missouri | United States | 63141 |
179 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65802 |
180 | St. John's Regional Health Center | Springfield | Missouri | United States | 65804 |
181 | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | United States | 65807 |
182 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
183 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
184 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59102 |
185 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
186 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
187 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
188 | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | United States | 59405 |
189 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
190 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
191 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
192 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
193 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
194 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
195 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
196 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109 |
197 | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | United States | 08053 |
198 | Valley Hospital - Ridgewood | Ridgewood | New Jersey | United States | 07450 |
199 | Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees | New Jersey | United States | 08043 |
200 | Lovelace Women's Hospital | Albuquerque | New Mexico | United States | 87109 |
201 | Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | Albuquerque | New Mexico | United States | 87110 |
202 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87131-5636 |
203 | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York | United States | 10461 |
204 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
205 | Beth Israel Medical Center - Petrie Division | New York | New York | United States | 10003-3803 |
206 | St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York | New York | United States | 10025 |
207 | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | United States | 10032 |
208 | Dyson Center for Cancer Care at Vassar Brothers Medical Center | Poughkeepsie | New York | United States | 12601-3990 |
209 | Saint Francis Hospital Cancer Center | Poughkeepsie | New York | United States | 12601 |
210 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
211 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7295 |
212 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
213 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
214 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
215 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
216 | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | United States | 44307 |
217 | Mary Rutan Hospital | Bellefontaine | Ohio | United States | 43311 |
218 | Wood County Oncology Center | Bowling Green | Ohio | United States | 43402 |
219 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
220 | Good Samaritan Hospital Cancer Treatment Center | Cincinnati | Ohio | United States | 45220 |
221 | Bethesda North Hospital | Cincinnati | Ohio | United States | 45242 |
222 | North Coast Cancer Care - Clyde | Clyde | Ohio | United States | 43410 |
223 | CCOP - Columbus | Columbus | Ohio | United States | 43215 |
224 | Grant Medical Center Cancer Care | Columbus | Ohio | United States | 43215 |
225 | Mount Carmel Health - West Hospital | Columbus | Ohio | United States | 43222 |
226 | Doctors Hospital at Ohio Health | Columbus | Ohio | United States | 43228 |
227 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
228 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
229 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
230 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
231 | Community Cancer Center | Elyria | Ohio | United States | 44035 |
232 | Hematology Oncology Center | Elyria | Ohio | United States | 44035 |
233 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
234 | Middletown Regional Hospital | Franklin | Ohio | United States | 45005-1066 |
235 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
236 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
237 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
238 | Lima Memorial Hospital | Lima | Ohio | United States | 45804 |
239 | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
240 | Northwest Ohio Oncology Center | Maumee | Ohio | United States | 43537-1839 |
241 | Knox Community Hospital | Mount Vernon | Ohio | United States | 43050 |
242 | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
243 | Fisher-Titus Medical Center | Norwalk | Ohio | United States | 44857 |
244 | St. Charles Mercy Hospital | Oregon | Ohio | United States | 43616 |
245 | Toledo Clinic - Oregon | Oregon | Ohio | United States | 43616 |
246 | North Coast Cancer Care, Incorporated | Sandusky | Ohio | United States | 44870 |
247 | Community Hospital of Springfield and Clark County | Springfield | Ohio | United States | 45505 |
248 | Mercy Hospital of Tiffin | Tiffin | Ohio | United States | 44883 |
249 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
250 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43617 |
251 | St. Anne Mercy Hospital | Toledo | Ohio | United States | 43623 |
252 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
253 | Fulton County Health Center | Wauseon | Ohio | United States | 43567 |
254 | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | United States | 43081 |
255 | Clinton Memorial Hospital | Wilmington | Ohio | United States | 45177 |
256 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
257 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
258 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
259 | Providence Milwaukie Hospital | Milwaukie | Oregon | United States | 97222 |
260 | Providence Newberg Medical Center | Newberg | Oregon | United States | 97132 |
261 | Willamette Falls Hospital | Oregon City | Oregon | United States | 97045 |
262 | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | United States | 97213-2967 |
263 | Adventist Medical Center | Portland | Oregon | United States | 97216 |
264 | CCOP - Columbia River Oncology Program | Portland | Oregon | United States | 97225 |
265 | Providence St. Vincent Medical Center | Portland | Oregon | United States | 97225 |
266 | Sacred Heart Hospital | Allentown | Pennsylvania | United States | 18102 |
267 | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18105 |
268 | St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania | United States | 18015 |
269 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
270 | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | United States | 17822-0001 |
271 | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | United States | 18201 |
272 | Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
273 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17604 |
274 | Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301-1792 |
275 | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107-5541 |
276 | Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
277 | UPMC Cancer Centers | Pittsburgh | Pennsylvania | United States | 15232 |
278 | Geisinger Medical Group - Scenery Park | State College | Pennsylvania | United States | 16801 |
279 | Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center | Upland | Pennsylvania | United States | 19013 |
280 | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
281 | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
282 | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania | United States | 17405 |
283 | Women and Infants Hospital of Rhode Island | Providence | Rhode Island | United States | 02905 |
284 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
285 | Hilton Head Regional Medical Center | Hilton Head Island | South Carolina | United States | 29926 |
286 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
287 | Lexington Medical Center | West Columbia | South Carolina | United States | 29169 |
288 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
289 | Nashville Breast Center | Nashville | Tennessee | United States | 37203 |
290 | MBCCOP - Meharry Medical College - Nashville | Nashville | Tennessee | United States | 37208-3599 |
291 | Baptist Hospital | Nashville | Tennessee | United States | 37236 |
292 | Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | United States | 79106 |
293 | Baylor University Medical Center - Dallas | Dallas | Texas | United States | 75246 |
294 | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | United States | 75390 |
295 | M. D. Anderson Cancer Center at University of Texas | Houston | Texas | United States | 77030-4009 |
296 | Doctor's Hospital of Laredo | Laredo | Texas | United States | 78041 |
297 | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | United States | 79410-1894 |
298 | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | United States | 84112 |
299 | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | United States | 22401 |
300 | Surgical Oncology Associates | Newport News | Virginia | United States | 23606 |
301 | Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
302 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
303 | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | United States | 99204 |
304 | Southwest Washington Medical Center Cancer Center | Vancouver | Washington | United States | 98668 |
305 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506 |
306 | Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg | West Virginia | United States | 26102 |
307 | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54301-3526 |
308 | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | United States | 54303 |
309 | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | United States | 54303 |
310 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
311 | Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
312 | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | United States | 54601 |
313 | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
314 | Vince Lombardi Cancer Clinic - Marinette | Marinette | Wisconsin | United States | 54143 |
315 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53201-0342 |
316 | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
317 | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
318 | Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
319 | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | United States | 54154 |
320 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
321 | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235 |
322 | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | United States | 53188 |
323 | Aurora Women's Pavilion of West Allis Memorial Hospital | West Allis | Wisconsin | United States | 53227 |
324 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Judy Boughey, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACOSOG-Z1071
- ACOSOG-Z1071
- CDR0000640100
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | cN1 Cohort | cN2 Cohort | cN3 Patients (Ineligible) |
---|---|---|---|
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Patients who were staged according to the AJCC staging system as cN3. |
Period Title: Overall Study | |||
STARTED | 707 | 47 | 2 |
COMPLETED | 663 | 38 | 0 |
NOT COMPLETED | 44 | 9 | 2 |
Baseline Characteristics
Arm/Group Title | cN1 Cohort | cN2 Cohort | Total |
---|---|---|---|
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Total of all reporting groups |
Overall Participants | 663 | 38 | 701 |
Age, Customized (participants) [Number] | |||
18-39 years old |
120
18.1%
|
4
10.5%
|
124
17.7%
|
40-49 years old |
213
32.1%
|
15
39.5%
|
228
32.5%
|
50-59 years old |
197
29.7%
|
10
26.3%
|
207
29.5%
|
60-69 years old |
112
16.9%
|
5
13.2%
|
117
16.7%
|
greater than 70 years old |
21
3.2%
|
4
10.5%
|
25
3.6%
|
Sex: Female, Male (Count of Participants) | |||
Female |
663
100%
|
38
100%
|
701
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
United States |
663
100%
|
38
100%
|
701
100%
|
Outcome Measures
Title | False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN1 Breast Cancer [cN1 Cohort] |
---|---|
Description | False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN1 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. A 2-sided Bayesian credible interval (BCI) for the true FNR was constructed. |
Time Frame | At time of surgery |
Outcome Measure Data
Analysis Population Description |
---|
Of the cN1 Cohort patients who Started the study (see Participant Flow), only patients with residual nodal disease were included in this analysis. |
Arm/Group Title | cN1 Cohort |
---|---|
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. |
Measure Participants | 525 |
Number (90% Confidence Interval) [percentage of participants] |
12.6
1.9%
|
Title | False Negative Rate (FNR) for Sentinel Lymph Node (SLN) Surgery After Chemotherapy When at Least 2 SLNs Were Excised in Women Initially Presenting With Biopsy-proven cN2 Breast Cancer [cN2 Cohort] |
---|---|
Description | False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy when at least 2 SLNs were excised in women initially presenting with biopsy-proven cN2 breast cancer, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients initially presenting with biopsy-proven cN1 breast cancer with at least one positive lymph node by SLN or ALND multiplied by 100. An interval estimate of the SLN false negative rate will be constructed using the Duffy-Santner approach. |
Time Frame | At time of surgery |
Outcome Measure Data
Analysis Population Description |
---|
Of the cN2 Cohort patients who Started the study (see Participant Flow), only patients with residual nodal disease were included in this analysis. |
Arm/Group Title | cN2 Cohort |
---|---|
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. |
Measure Participants | 38 |
Number (95% Confidence Interval) [percentage of false-negative SLN finding] |
0
|
Title | False-negative Rate (FNR) Under the Selection Process by Axillary Ultrasound (AUS) Status After Completion of Neoadjuvant Chemotherapy (NAC) |
---|---|
Description | False negative rate (FNR) (percentage) for sentinel lymph node (SLN) surgery after chemotherapy in women with normal AUS and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection (ALND) divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100. |
Time Frame | At the time of surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Post-chemotherapy AUS Normal |
---|---|
Arm/Group Description | Patients with lymph nodes classified as normal if the radiologist was unable to visualize any lymph nodes on axillary ultrasound (AUS) or indicated that the lymph nodes were normal in morphologic appearance. |
Measure Participants | 470 |
Number (90% Confidence Interval) [percentage of false-negative SLN finding] |
12.6
|
Title | Node Status After Preoperative Chemotherapy, as Measured by the Total Number of Positive Nodes (SLN+ALND) |
---|---|
Description | Node status of patients after preoperative chemotherapy, as measured by the total number of positive nodes (SLN+ALND). Patients will be classified as node positive if they were determined to have at least one positive lymph node by SLN or ALND. |
Time Frame | At time of surgery |
Outcome Measure Data
Analysis Population Description |
---|
Patients with post-chemotherapy AUS results were included in this analysis. |
Arm/Group Title | Post-chemotherapy AUS Normal | Post-chemotherapy AUS Suspicious |
---|---|---|
Arm/Group Description | Patients with lymph nodes classified as normal if the radiologist was unable to visualize any lymph nodes on axillary ultrasound (AUS) or indicated that the lymph nodes were normal in morphologic appearance. | Patients with lymph nodes with abnormal morphology on AUS were classified as suspicious. |
Measure Participants | 430 | 181 |
0 |
171
25.8%
|
47
123.7%
|
1-3 |
173
26.1%
|
89
234.2%
|
4-10 |
42
6.3%
|
28
73.7%
|
>10 |
10
1.5%
|
7
18.4%
|
Missing/Unknown |
34
5.1%
|
10
26.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | cN1 Cohort, Post-chemotherapy AUS Suspicious |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | ||
Method | t-test, 2 sided | |
Comments |
Title | Pathologic Complete Nodal Response (pCR) Rate |
---|---|
Description | Pathologic complete nodal response (pCR) rate (percentage) wherein a nodal pCR is pathologically node-negative (pN0) on the basis of SLN surgery and ALND. A 95% binomial confidence interval was constructed for the pCR rate. |
Time Frame | At the time of surgery |
Outcome Measure Data
Analysis Population Description |
---|
Patients in cN1 and cN2 Cohort who had at least two SLNs excised and went on to complete ALND were included in this analysis. |
Arm/Group Title | cN1 Cohort | cN2 Cohort |
---|---|---|
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. |
Measure Participants | 525 | 26 |
Number (95% Confidence Interval) [percentage of SLN surgery/ALND] |
41.0
|
46.1
|
Title | Residual Cancer Burden Class |
---|---|
Description | Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The calculated RCB index value can also be categorized as one of four RCB classes. The number of patients classified in the four RCB classes along with the number of patients missing this data by cohort are reported below. RCB of 0 represents a path complete response while increasing levels (I, then II, then III) indicate an increase in the 'amount' of residual disease remaining. |
Time Frame | At time of surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | cN1 Cohort | cN2 Cohort |
---|---|---|
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. |
Measure Participants | 663 | 38 |
missing data |
162
24.4%
|
6
15.8%
|
0 |
182
27.5%
|
13
34.2%
|
I |
33
5%
|
0
0%
|
II |
136
20.5%
|
10
26.3%
|
III |
150
22.6%
|
9
23.7%
|
Title | Disease-Free Survival |
---|---|
Description | |
Time Frame | Up to 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | 1-2 weeks post surgery | |||
---|---|---|---|---|
Adverse Event Reporting Description | Each CTCAE term is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who started treatment & were evaluated for AEs. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and are in the SAE table. | |||
Arm/Group Title | cN1 Cohort | cN2 Cohort | ||
Arm/Group Description | Patients who were staged according to the AJCC staging system as cN1 (disease in movable axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | Patients who were staged according to the AJCC staging system as cN2 (disease in fixed or matted axillary lymph nodes) and plan to receive or have received neoadjuvant chemotherapy are eligible. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 12 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy (per surgeon discretion) including both sentinel lymph node surgery and axillary lymph node dissection. | ||
All Cause Mortality |
||||
cN1 Cohort | cN2 Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/676 (0.1%) | 0/39 (0%) | ||
Serious Adverse Events |
||||
cN1 Cohort | cN2 Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/676 (0.9%) | 0/39 (0%) | ||
Blood and lymphatic system disorders | ||||
Hemoglobin decreased | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
General disorders | ||||
Multi-organ failure | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Infections and infestations | ||||
Infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Skin infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Wound infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Dehydration | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Upper extremity dysfunction | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
cN1 Cohort | cN2 Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 192/676 (28.4%) | 9/39 (23.1%) | ||
Blood and lymphatic system disorders | ||||
Hemoglobin decreased | 10/676 (1.5%) | 10 | 1/39 (2.6%) | 1 |
Lymphatic disorder | 4/676 (0.6%) | 4 | 2/39 (5.1%) | 2 |
Ear and labyrinth disorders | ||||
Ear disorder | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Eye disorders | ||||
Eye disorder | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Eye pain | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Gastrointestinal disorders | ||||
Constipation | 13/676 (1.9%) | 13 | 0/39 (0%) | 0 |
Diarrhea | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Ileus | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Nausea | 15/676 (2.2%) | 15 | 0/39 (0%) | 0 |
Rectal pain | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Vomiting | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
General disorders | ||||
Chest pain | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Chills | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Edema limbs | 15/676 (2.2%) | 15 | 0/39 (0%) | 0 |
Fatigue | 41/676 (6.1%) | 41 | 3/39 (7.7%) | 3 |
Fever | 5/676 (0.7%) | 5 | 0/39 (0%) | 0 |
Injection site reaction | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Localized edema | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Pain | 54/676 (8%) | 54 | 2/39 (5.1%) | 2 |
Infections and infestations | ||||
Catheter related infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Device related infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Peripheral nerve infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Skin infection | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Soft tissue infection | 1/676 (0.1%) | 1 | 1/39 (2.6%) | 1 |
Upper respiratory infection | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Urinary tract infection | 1/676 (0.1%) | 1 | 1/39 (2.6%) | 1 |
Wound infection | 6/676 (0.9%) | 6 | 0/39 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Bruising | 5/676 (0.7%) | 5 | 1/39 (2.6%) | 1 |
Postoperative hemorrhage | 1/676 (0.1%) | 1 | 1/39 (2.6%) | 1 |
Seroma | 16/676 (2.4%) | 16 | 2/39 (5.1%) | 2 |
Small intestinal anastomotic leak | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Wound dehiscence | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Investigations | ||||
Gamma-glutamyltransferase increased | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Lymphocyte count decreased | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Platelet count decreased | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Weight loss | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Anorexia | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Blood glucose increased | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Dehydration | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Serum albumin decreased | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Serum calcium decreased | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Serum glucose decreased | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Serum magnesium decreased | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Serum potassium decreased | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Serum sodium decreased | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Arthritis | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Back pain | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Chest wall pain | 15/676 (2.2%) | 15 | 1/39 (2.6%) | 1 |
Joint disorder | 19/676 (2.8%) | 19 | 1/39 (2.6%) | 1 |
Joint pain | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Joint range of motion decreased cervical spine | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Muscle weakness upper limb | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Musculoskeletal disorder | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Myalgia | 6/676 (0.9%) | 6 | 0/39 (0%) | 0 |
Pain in extremity | 22/676 (3.3%) | 22 | 0/39 (0%) | 0 |
Upper extremity dysfunction | 11/676 (1.6%) | 11 | 0/39 (0%) | 0 |
Nervous system disorders | ||||
Dizziness | 4/676 (0.6%) | 4 | 0/39 (0%) | 0 |
Headache | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Neurological disorder NOS | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Peripheral motor neuropathy | 7/676 (1%) | 7 | 0/39 (0%) | 0 |
Peripheral sensory neuropathy | 46/676 (6.8%) | 46 | 1/39 (2.6%) | 1 |
Seizure | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Syncope | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Taste alteration | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Psychiatric disorders | ||||
Anxiety | 5/676 (0.7%) | 5 | 0/39 (0%) | 0 |
Confusion | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Depression | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Insomnia | 7/676 (1%) | 7 | 0/39 (0%) | 0 |
Renal and urinary disorders | ||||
Cystitis | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Urinary frequency | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Urinary retention | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Urine discoloration | 8/676 (1.2%) | 8 | 0/39 (0%) | 0 |
Reproductive system and breast disorders | ||||
Breast pain | 39/676 (5.8%) | 39 | 2/39 (5.1%) | 2 |
Ovulation pain | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Vaginal pain | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Atelectasis | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Cough | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Dyspnea | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Pharyngolaryngeal pain | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||
Alopecia | 4/676 (0.6%) | 4 | 0/39 (0%) | 0 |
Chest wall necrosis | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Decubitus ulcer | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Nail disorder | 2/676 (0.3%) | 2 | 2/39 (5.1%) | 2 |
Pruritus | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Rash desquamating | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Skin disorder | 9/676 (1.3%) | 9 | 0/39 (0%) | 0 |
Skin hyperpigmentation | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Sweating | 2/676 (0.3%) | 2 | 0/39 (0%) | 0 |
Vascular disorders | ||||
Hematoma | 11/676 (1.6%) | 11 | 0/39 (0%) | 0 |
Hot flashes | 4/676 (0.6%) | 4 | 0/39 (0%) | 0 |
Lymphedema | 1/676 (0.1%) | 1 | 0/39 (0%) | 0 |
Thrombosis | 3/676 (0.4%) | 3 | 0/39 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Judy C. Boughey, MD |
---|---|
Organization | Mayo Clinic |
Phone | 507-284-3629 |
boughey.judy@mayo.edu |
- ACOSOG-Z1071
- ACOSOG-Z1071
- CDR0000640100