Adj TC + Herceptin Early Stage Breast Cancer
Study Details
Study Description
Brief Summary
The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: TC+H On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel (Taxotere) 75 mg/m2 IV (over 1 hour), plus cyclophosphamide (Cytoxan) 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. |
Drug: Taxotere
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Other Names:
Drug: Cytoxan
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Other Names:
Drug: Herceptin
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. [2 years]
DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.
Secondary Outcome Measures
- Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. [2 years]
OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
- DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. [2 years]
DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.
- OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. [2 years]
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Eligibility Criteria
Criteria
Inclusion Criteria:
A woman will be eligible for inclusion in this study if she meets all of the following criteria:
-
Has HER2+ (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2; patients with equivocal FISH ratio results 1.8-2.2 are also eligible if 3+ IHC) (Appendix IX); Stage I, IIA, IIB, or IIIA T1-3N1-3M0 disease. At the discretion of the Treating Physician, patients with 4+ nodes with other factors such as patient choice, older age, preexisting cardiac disease with normal MUGA or ECHO may be enrolled into a separate subgroup.
-
Has operable, histologically confirmed, invasive carcinoma of the breast.
-
Has known ER and PR status
-
Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VII)
-
Has had no prior chemotherapy unless it was given >5 years ago for breast cancer or other cancer
-
Has an ECOG Performance Status (PS) 0-1
-
Age >18 to <70 years old.
-
Has laboratory values of: See protocol for specific details
-
Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
-
Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node or axillary dissection.
-
It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician
-
Has no evidence of metastatic disease by physical examination and x-ray; appropriate scans as needed by each individual patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease.
-
Has normal cardiac function as evidenced by a LVEF >50%, but must be within normal limits (WNL) by institutional standard, as determined by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO). The same modality must be used throughout the study to evaluate LVEF. Ejection fraction (EF) as determined by ECHO must be WNL by institutional standard.
-
Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause]).
-
If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
-
Has signed a Patient Informed Consent Form
-
Has signed a Patient Authorization Form
Exclusion Criteria:
A woman will be excluded from this study if she meets any of the following criteria:
-
Has any evidence of disease following complete surgical resection of the primary tumor and metastatic workup
-
Has Stage IIIB breast cancer (T4 disease; ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).
-
Has Stage IV breast cancer (M1 disease on TNM staging system)
-
Had prior chemotherapy for breast cancer or other cancer within the last 5 years (no neoadjuvant chemotherapy in this study is permitted)
-
Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
-
Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA) Class II or greater heart failure (see Appendix III), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic changes
-
Has abnormal baseline MUGA (or ECHO) (<50%, or less than institutional LLN)
-
Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Adjuvant hormonal therapy, if needed, may be given during radiation therapy and during treatment with trastuzumab after completion of chemotherapy.
-
Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
-
Has peripheral neuropathy >Grade 1
-
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
-
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
-
Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
-
Is an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible
-
Is a pregnant or breastfeeding woman
-
Is deemed unable to comply with requirements of study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Birmingham Hematology and Oncology | Birmingham | Alabama | United States | 35205 |
2 | Hematology Oncology Associates | Phoenix | Arizona | United States | 85012 |
3 | Northern AZ Hematology & Oncology Associates | Sedona | Arizona | United States | 86336 |
4 | Arizona Oncology Associates DBA HOPE | Tucson | Arizona | United States | 85704 |
5 | Rocky Mountain Cancer Center-Rose | Denver | Colorado | United States | 80220 |
6 | Connecticut Oncology & Hematology, LLP | Torrington | Connecticut | United States | 06790 |
7 | Florida Cancer Institute | New Port richey | Florida | United States | 34655 |
8 | Ocala Oncology Center | Ocala | Florida | United States | 34474 |
9 | Cancer Centers of Florida, P.A. | Ocoee | Florida | United States | 34761 |
10 | Hematology Oncology Associates of IL | Chicago | Illinois | United States | 60611 |
11 | Cancer Care & Hematology Specialists of Chicagoland | Niles | Illinois | United States | 60714 |
12 | Central Indiana Cancer Centers | Indianapolis | Indiana | United States | 46227 |
13 | Hope Center | Terre Haute | Indiana | United States | 47802 |
14 | Kansas City Cancer Centers-Southwest | Overland Park | Kansas | United States | 66210 |
15 | Maryland Oncology Hematology, P.A. | Columbia | Maryland | United States | 21044 |
16 | Alliance Hematology Oncology P.A. | Westminster | Maryland | United States | 21157 |
17 | Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | United States | 55404 |
18 | Missouri Cancer Associates | Columbia | Missouri | United States | 65201 |
19 | Arch Medical Services, Inc. | St. Louis | Missouri | United States | 63141 |
20 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89052 |
21 | Hematology-Oncology Associates of NNJ, P.A. | Morristown | New Jersey | United States | 07960 |
22 | New Mexico Cancer Care Associates | Santa Fe | New Mexico | United States | 87505 |
23 | New York Oncology Hematology, P.C. | Albany | New York | United States | 12006 |
24 | Ruth Oratz MD | New York | New York | United States | 10016 |
25 | Interlakes Oncology Hematology, PC | Rochester | New York | United States | 14623 |
26 | Cancer Centers of North Carolina | Raleigh | North Carolina | United States | 27607 |
27 | Greater Dayton Cancer Center | Kettering | Ohio | United States | 45409 |
28 | Willamette Valley Cancer Center | Eugene | Oregon | United States | 97401 |
29 | Medical Oncology Associates | Kingston | Pennsylvania | United States | 18704 |
30 | Cancer Centers of the Carolinas | Greenville | South Carolina | United States | 29605 |
31 | Texas Cancer Center-Abilene (South) | Abilene | Texas | United States | 79606 |
32 | Texas Oncology, P.A.-Amarillo | Amarillo | Texas | United States | 79106 |
33 | Texas Cancer Center | Arlington | Texas | United States | 76014 |
34 | Texas Oncology Cancer Center | Austin | Texas | United States | 78731 |
35 | Mamie McFaddin Ward Cancer Center | Beaumont | Texas | United States | 77702 |
36 | Texas Oncology, P.A.-Bedford | Bedford | Texas | United States | 76022 |
37 | Texas Cancer Center at Medical City | Dallas | Texas | United States | 75230 |
38 | Texas Oncology, P.A. | Dallas | Texas | United States | 75231 |
39 | Methodist Charlton Cancer Ctr. | Dallas | Texas | United States | 75237 |
40 | Texas Oncology, P.A. | Dallas | Texas | United States | 75246 |
41 | Texas Cancer Center | Denton | Texas | United States | 76210 |
42 | El Paso Cancer Treatment Ctr | EL Paso | Texas | United States | 79915 |
43 | Texas Oncology, P.A. | Fort Worth | Texas | United States | 76104 |
44 | Texas Oncology, P.A. | Garland | Texas | United States | 75042 |
45 | Texas Oncology, P.A. | Houston | Texas | United States | 77024 |
46 | Lake Vista Cancer Center | Lewisville | Texas | United States | 75067 |
47 | Longview Cancer Center | Longview | Texas | United States | 75601 |
48 | South Texas Cancer Center-McAllen | McAllen | Texas | United States | 78503 |
49 | Texas Cancer Center of Mesquite | Mesquite | Texas | United States | 75150 |
50 | Allison Cancer Center | Midland | Texas | United States | 79701 |
51 | Texas Oncology-Odessa | Odessa | Texas | United States | 79761 |
52 | Paris Regional Cancer Center | Paris | Texas | United States | 75460 |
53 | San Antonio Tumor and Blood Clinic | San Antonio | Texas | United States | 78217 |
54 | HOAST-Medical Dr. | San Antonio | Texas | United States | 78229 |
55 | Texas Cancer Center-Sherman | Sherman | Texas | United States | 75090 |
56 | Texas Oncology Cancer Center-Sugar Land | Sugar Land | Texas | United States | 77479 |
57 | Tyler Cancer Center | Tyler | Texas | United States | 75702 |
58 | Texas Oncology Cancer Care and Research | Waco | Texas | United States | 76712 |
59 | Texas Oncology PA | Webster | Texas | United States | 77598 |
60 | Texoma Cancer Center | Wichita Falls | Texas | United States | 76310 |
61 | Fairfax Northern VA Hem-Onc PC | Fairfax | Virginia | United States | 22031 |
62 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
63 | Onc and Hem Associates of SW VA, Inc. | Salem | Virginia | United States | 24153 |
64 | Highline Medical Oncology | Burien | Washington | United States | 98166 |
65 | Puget Sound Cancer Center-Edmonds | Edmonds | Washington | United States | 98026 |
66 | Puget Sound Cancer Center-Seattle | Seattle | Washington | United States | 98133 |
67 | Cancer Care Northwest-South | Spokane | Washington | United States | 99202 |
68 | Northwest Cancer Specialists-Vancouver | Vancouver | Washington | United States | 98684 |
69 | Yakima Valley Mem Hosp/North Star Lodge | Yakima | Washington | United States | 98902 |
Sponsors and Collaborators
- US Oncology Research
- Sanofi
Investigators
- Principal Investigator: Stephen E Jones, MD, US Oncology Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06-038
- 11270
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | TC+H |
---|---|
Arm/Group Description | This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. |
Period Title: Overall Study | |
STARTED | 493 |
COMPLETED | 411 |
NOT COMPLETED | 82 |
Baseline Characteristics
Arm/Group Title | TC+H |
---|---|
Arm/Group Description | docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin) |
Overall Participants | 493 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
55.1
(10.1)
|
Sex: Female, Male (Count of Participants) | |
Female |
493
100%
|
Male |
0
0%
|
Race/Ethnicity, Customized (participants) [Number] | |
Caucasian |
414
84%
|
Black |
36
7.3%
|
Hispanic |
27
5.5%
|
Asian |
12
2.4%
|
Indian |
1
0.2%
|
Other |
3
0.6%
|
Region of Enrollment (participants) [Number] | |
United States |
493
100%
|
Outcome Measures
Title | Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. |
---|---|
Description | DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population. Patients were excluded if their TOP2A amplification were unknown. |
Arm/Group Title | TOP2A-amplified Group | TOP2A-nonamplified Group |
---|---|---|
Arm/Group Description | FISH ratio of TOP2A gene copy number was 2 or greater. | FISH ratio of TOP2A gene copy number was less than 2. |
Measure Participants | 190 | 248 |
Number (95% Confidence Interval) [probability of disease-free survival] |
0.978
|
0.979
|
Title | Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. |
---|---|
Description | OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population. Patients were excluded if their TOP2A amplification were unknown. |
Arm/Group Title | TOP2A-amplified Group | TOP2A-nonamplified Group |
---|---|---|
Arm/Group Description | FISH ratio of TOP2A gene copy number was 2 or greater. | FISH ratio of TOP2A gene copy number was less than 2. |
Measure Participants | 190 | 248 |
Number (95% Confidence Interval) [probability of overall survival] |
0.995
|
0.988
|
Title | DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. |
---|---|
Description | DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population. Patients were excluded if their cMYC amplification were unknown. |
Arm/Group Title | cMYC-amplified Group | cMYC-nonamplified Group |
---|---|---|
Arm/Group Description | FISH ratio of cMYC gene copy number was 2 or greater. | FISH ratio of cMYC gene copy number was less than 2. |
Measure Participants | 99 | 337 |
Number (95% Confidence Interval) [probability of disease-free survival] |
0.968
|
0.981
|
Title | OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. |
---|---|
Description | OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
ITT population. Patients were excluded if their cMYC amplification were unknown. |
Arm/Group Title | cMYC-amplified Group | cMYC-nonamplified Group |
---|---|---|
Arm/Group Description | FISH ratio of cMYC gene copy number was 2 or greater. | FISH ratio of cMYC gene copy number was less than 2. |
Measure Participants | 99 | 337 |
Number (95% Confidence Interval) [probability of overall survival] |
0.990
|
0.991
|
Adverse Events
Time Frame | During the whole treatment period, up to 30 days following last dose. | |
---|---|---|
Adverse Event Reporting Description | For treated patients only, assessed at each treatment visit. | |
Arm/Group Title | TC+H | |
Arm/Group Description | docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin) | |
All Cause Mortality |
||
TC+H | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
TC+H | ||
Affected / at Risk (%) | # Events | |
Total | 51/486 (10.5%) | |
Blood and lymphatic system disorders | ||
ANEMIA | 1/486 (0.2%) | 1 |
NEUTROPENIA | 4/486 (0.8%) | 5 |
Cardiac disorders | ||
FIBRILLATION ATRIAL | 1/486 (0.2%) | 1 |
Gastrointestinal disorders | ||
ABDOMINAL PAIN | 2/486 (0.4%) | 2 |
BLOATING | 1/486 (0.2%) | 1 |
BOWEL PERFORATION | 1/486 (0.2%) | 1 |
COLITIS | 1/486 (0.2%) | 1 |
DEHYDRATION | 5/486 (1%) | 6 |
DIARRHEA | 5/486 (1%) | 5 |
GASTRIC INFLAMMATION | 1/486 (0.2%) | 1 |
NAUSEA | 3/486 (0.6%) | 3 |
NAUSEA AND VOMITING | 1/486 (0.2%) | 1 |
VOMITING | 1/486 (0.2%) | 1 |
General disorders | ||
FEVER | 5/486 (1%) | 5 |
PAIN | 1/486 (0.2%) | 1 |
Hepatobiliary disorders | ||
HEPATIC ENZYMES INCREASED | 1/486 (0.2%) | 1 |
LIVER FUNCTION TESTS MULTIPLE ABNORM | 1/486 (0.2%) | 1 |
Infections and infestations | ||
CELLULITIS | 4/486 (0.8%) | 4 |
CELLULITIS BREAST | 1/486 (0.2%) | 1 |
DIVERTICULITIS | 1/486 (0.2%) | 1 |
FEBRILE NEUTROPENIA | 22/486 (4.5%) | 23 |
INFECTION | 1/486 (0.2%) | 1 |
MASTITIS | 1/486 (0.2%) | 1 |
MUCOSITIS NOS | 1/486 (0.2%) | 1 |
Metabolism and nutrition disorders | ||
HYPOKALEMIA | 1/486 (0.2%) | 1 |
Nervous system disorders | ||
HYPERSENSITIVITY REACTION (NOS) | 1/486 (0.2%) | 1 |
SHOCK | 1/486 (0.2%) | 1 |
SYNCOPE | 2/486 (0.4%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||
ASPIRATION | 1/486 (0.2%) | 1 |
LUNG FIBROSIS INTERSTITIAL | 1/486 (0.2%) | 1 |
PNEUMONIA | 3/486 (0.6%) | 3 |
PULMONARY INFILTRATION | 1/486 (0.2%) | 1 |
SHORTNESS OF BREATH | 1/486 (0.2%) | 1 |
Vascular disorders | ||
THROMBOSIS ARTERIAL LEG | 1/486 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
TC+H | ||
Affected / at Risk (%) | # Events | |
Total | 481/486 (99%) | |
Blood and lymphatic system disorders | ||
ANEMIA | 131/486 (27%) | 227 |
EDEMA | 86/486 (17.7%) | 120 |
LEUCOPENIA | 84/486 (17.3%) | 179 |
NEUTROPENIA | 247/486 (50.8%) | 597 |
Cardiac disorders | ||
CARDIAC INSUFFICIENCY | 29/486 (6%) | 34 |
Gastrointestinal disorders | ||
ANOREXIA | 56/486 (11.5%) | 69 |
CONSTIPATION | 90/486 (18.5%) | 112 |
DIARRHEA | 183/486 (37.7%) | 276 |
DYSGUESIA | 73/486 (15%) | 86 |
GASTROESOPHAGEAL REFLUX | 63/486 (13%) | 68 |
NAUSEA | 216/486 (44.4%) | 315 |
VOMITING | 45/486 (9.3%) | 53 |
General disorders | ||
FATIGUE | 284/486 (58.4%) | 487 |
FEVER | 42/486 (8.6%) | 55 |
HEADACHE | 55/486 (11.3%) | 67 |
HOT FLASHES | 50/486 (10.3%) | 59 |
INSOMNIA | 49/486 (10.1%) | 61 |
PAIN | 64/486 (13.2%) | 91 |
Infections and infestations | ||
MUCOSITIS | 89/486 (18.3%) | 115 |
Musculoskeletal and connective tissue disorders | ||
ARTHRALGIA | 66/486 (13.6%) | 77 |
MYALGIA | 81/486 (16.7%) | 96 |
Nervous system disorders | ||
NEUROPATHY | 99/486 (20.4%) | 125 |
Respiratory, thoracic and mediastinal disorders | ||
SHORTNESS OF BREATH | 41/486 (8.4%) | 46 |
Skin and subcutaneous tissue disorders | ||
ALOPECIA | 339/486 (69.8%) | 395 |
MUCOSAL | 32/486 (6.6%) | 39 |
NAIL DISORDER | 34/486 (7%) | 38 |
RASH | 104/486 (21.4%) | 141 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT 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 | Dr. Stephen E Jones |
---|---|
Organization | US Oncology Research, McKesson Specialty Health |
Phone | 832-381-7580 |
steve.jones@usoncology.com |
- 06-038
- 11270