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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00881361
Collaborator
National Cancer Institute (NCI) (NIH)
756
324
1
2.3

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
  • Drug: systemic chemotherapy
  • Procedure: axillary lymph node dissection
  • Procedure: neoadjuvant therapy
  • Procedure: sentinel lymph node biopsy
  • Procedure: therapeutic conventional surgery
  • Procedure: ultrasound imaging
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:
  1. 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:
  1. 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.

  2. 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.

  3. 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.

  4. 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

Study Type:
Interventional
Actual Enrollment :
756 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
Actual Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Nov 1, 2012

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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Disease-Free Survival [Up to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Eligibility Criteria:
  1. ≥ 18 years old

  2. ECOG/Zubrod Performance Status 0-1

  3. 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.

  4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer).

  5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy.

  6. 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.

  7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.

  8. 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.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00881361
Other Study ID Numbers:
  • ACOSOG-Z1071
  • ACOSOG-Z1071
  • CDR0000640100
First Posted:
Apr 15, 2009
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms:

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

1. Primary Outcome
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%
2. Secondary Outcome
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
3. Secondary Outcome
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
4. Secondary Outcome
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
5. Secondary Outcome
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
6. Secondary Outcome
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%
7. Other Pre-specified Outcome
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

[Not Specified]

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
Email boughey.judy@mayo.edu
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00881361
Other Study ID Numbers:
  • ACOSOG-Z1071
  • ACOSOG-Z1071
  • CDR0000640100
First Posted:
Apr 15, 2009
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021