Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
NCT ID: NCT00004067
Last Updated: 2021-04-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
2130 participants
Study Classification
INTERVENTIONAL
Study Start Date
2000-02-29
Study Completion Date
2019-11-30
Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.
PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.
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Detailed Description
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OBJECTIVES:
* Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®) in women with operable, node-positive breast cancer that overexpresses HER2.
* Compare the effect of these regimens on disease-free and overall survival of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (1-3 vs 4-9 vs 10 or more), administration of hormonal therapy (tamoxifen vs anastrozole vs neither), surgery/radiotherapy (lumpectomy plus breast irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy without radiotherapy vs mastectomy with radiotherapy), paclitaxel schedule (every 3 weeks vs weekly), and participating center. Patients are randomized to one of two treatment arms.
* Arm 1: Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Approximately 3 weeks after the last course, patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR paclitaxel IV over 1 hour once weekly for 12 weeks (12 doses).
* Arm 2: Patients receive chemotherapy as in arm I and trastuzumab (Herceptin®) IV over 90 minutes on day 1 of the first course of paclitaxel. Trastuzumab is then administered IV over 30 minutes weekly for 51 weeks, beginning on day 8.
All patients with estrogen or progesterone receptor-positive tumors receive hormonal therapy\* for at least 5 years, beginning within 3-12 weeks after the last dose of chemotherapy. Patients who have received prior tamoxifen for prevention may be treated with additional tamoxifen for no more than 5 years at the discretion of the principal investigator (PI).
NOTE: \*Other hormonal therapeutic agents are allowed in sequence with or as an alternative to tamoxifen therapy.
All patients previously treated with lumpectomy undergo breast irradiation beginning after completion of chemotherapy and concurrently with trastuzumab (in arm 2) administration. Patients previously treated with mastectomy may also receive radiotherapy. Radiotherapy is administered daily for 5-6 weeks.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,700 patients will be accrued for this study within 4.75 years.
* Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®) in women with operable, node-positive breast cancer that overexpresses HER2.
* Compare the effect of these regimens on disease-free and overall survival of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (1-3 vs 4-9 vs 10 or more), administration of hormonal therapy (tamoxifen vs anastrozole vs neither), surgery/radiotherapy (lumpectomy plus breast irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy without radiotherapy vs mastectomy with radiotherapy), paclitaxel schedule (every 3 weeks vs weekly), and participating center. Patients are randomized to one of two treatment arms.
* Arm 1: Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Approximately 3 weeks after the last course, patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR paclitaxel IV over 1 hour once weekly for 12 weeks (12 doses).
* Arm 2: Patients receive chemotherapy as in arm I and trastuzumab (Herceptin®) IV over 90 minutes on day 1 of the first course of paclitaxel. Trastuzumab is then administered IV over 30 minutes weekly for 51 weeks, beginning on day 8.
All patients with estrogen or progesterone receptor-positive tumors receive hormonal therapy\* for at least 5 years, beginning within 3-12 weeks after the last dose of chemotherapy. Patients who have received prior tamoxifen for prevention may be treated with additional tamoxifen for no more than 5 years at the discretion of the principal investigator (PI).
NOTE: \*Other hormonal therapeutic agents are allowed in sequence with or as an alternative to tamoxifen therapy.
All patients previously treated with lumpectomy undergo breast irradiation beginning after completion of chemotherapy and concurrently with trastuzumab (in arm 2) administration. Patients previously treated with mastectomy may also receive radiotherapy. Radiotherapy is administered daily for 5-6 weeks.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,700 patients will be accrued for this study within 4.75 years.
Conditions
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Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm 1: adriamycin + cyclophosphamide then taxol
Group Type
ACTIVE_COMPARATOR
adriamycin
Intervention Type
DRUG
60 mg/m2 IV push every 21 days for 4 cycles.
cyclophosphamide
Intervention Type
DRUG
600 mg/m2 IV every 21 days for 4 cycles
taxol
Intervention Type
DRUG
175 mg/m2 IV every 21 days for 4 cycles
Arm 2: adriamycin + cyclophosphamide then taxol + herceptin
Group Type
EXPERIMENTAL
herceptin
Intervention Type
BIOLOGICAL
4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
adriamycin
Intervention Type
DRUG
60 mg/m2 IV push every 21 days for 4 cycles.
cyclophosphamide
Intervention Type
DRUG
600 mg/m2 IV every 21 days for 4 cycles
taxol
Intervention Type
DRUG
175 mg/m2 IV every 21 days for 4 cycles
Interventions
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herceptin
4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
Intervention Type
BIOLOGICAL
adriamycin
60 mg/m2 IV push every 21 days for 4 cycles.
Intervention Type
DRUG
cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Intervention Type
DRUG
taxol
175 mg/m2 IV every 21 days for 4 cycles
Intervention Type
DRUG
Other Intervention Names
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trastuzumab
doxorubicin
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
* The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.
* All of the following staging criteria must be met:
* Primary tumor must be T1-3 by clinical and pathologic evaluation.
* Ipsilateral nodes must be cN0-1 by clinical evaluation.
* Ipsilateral nodes must be pN1, pN2a, or pN3a by pathologic evaluation.
* M0
* Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.
* The tumor must be invasive adenocarcinoma on histologic examination.
* The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score.
* Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization. "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.
* At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.
* Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is \> 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA. Please note that if a more accurate value is obtained from the review of the baseline MUGA, the corrected value must be submitted to the NSABP Biostatistical Center before the post-AC MUGA is performed.)
* At the time of randomization:
* The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or \<1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal).
* Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab.
* There must be postoperative evidence of adequate hepatic function, i.e., total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (\>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and alkaline phosphatase must be \<2.5 times the ULN for the lab; and the serum glutamic-oxaloacetic transaminase (SGOT \[AST\]) must be \<1.5 times the ULN for the lab.
* There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).
* Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.
* Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
* Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: Irradiation of any internal mammary nodes is prohibited in this trial.
* Special conditions for eligibility of lumpectomy patients: irradiation and surgery
* Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in addition to the following: Generally, lumpectomy should be reserved for tumors \<5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible. The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial. Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes.
* Special conditions for eligibility of mastectomy patients: irradiation. The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation.
* The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.
* All of the following staging criteria must be met:
* Primary tumor must be T1-3 by clinical and pathologic evaluation.
* Ipsilateral nodes must be cN0-1 by clinical evaluation.
* Ipsilateral nodes must be pN1, pN2a, or pN3a by pathologic evaluation.
* M0
* Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.
* The tumor must be invasive adenocarcinoma on histologic examination.
* The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score.
* Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization. "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.
* At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.
* Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is \> 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA. Please note that if a more accurate value is obtained from the review of the baseline MUGA, the corrected value must be submitted to the NSABP Biostatistical Center before the post-AC MUGA is performed.)
* At the time of randomization:
* The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or \<1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal).
* Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab.
* There must be postoperative evidence of adequate hepatic function, i.e., total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (\>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and alkaline phosphatase must be \<2.5 times the ULN for the lab; and the serum glutamic-oxaloacetic transaminase (SGOT \[AST\]) must be \<1.5 times the ULN for the lab.
* There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).
* Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.
* Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
* Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: Irradiation of any internal mammary nodes is prohibited in this trial.
* Special conditions for eligibility of lumpectomy patients: irradiation and surgery
* Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in addition to the following: Generally, lumpectomy should be reserved for tumors \<5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible. The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial. Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes.
* Special conditions for eligibility of mastectomy patients: irradiation. The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation.
Exclusion Criteria
* Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
* Primary tumor staged as T4 for any reason.
* Nodes staged as clinical N2 or N3 for any reason and nodes staged as pathologic pN2b, pN3b, or pN3c.
* Prior history of breast cancer, including DCIS (patients with a history of lobular carcinoma in situ \[LCIS\] are eligible).
* Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.
* Prior anthracycline or taxane therapy for any malignancy.
* Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)
* Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen as described in the protocol)
* Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
* Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes:
* Active cardiac disease:
* angina pectoris that requires the use of antianginal medication;
* cardiac arrhythmia requiring medication;
* severe conduction abnormality;
* clinically significant valvular disease;
* cardiomegaly on chest x-ray;
* ventricular hypertrophy on EKG; or
* patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.)
* History of cardiac disease:
* myocardial infarction documented as a clinical diagnosis or by EKG or any other tests;
* documented congestive heart failure; or
* documented cardiomyopathy.
* Psychiatric or addictive disorders that would preclude obtaining informed consent.
* Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.
* Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.
* Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.
* Concurrent treatment with other investigational agents.
* Sensitivity to benzyl alcohol.
* Special conditions for ineligibility of lumpectomy patients: irradiation and surgery. For patients treated by lumpectomy with axillary dissection, breast irradiation is required. Please see guidelines for radiation therapy in Appendix A. In addition, the following patients will also be ineligible:
* Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.
* Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
* Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.
* Primary tumor staged as T4 for any reason.
* Nodes staged as clinical N2 or N3 for any reason and nodes staged as pathologic pN2b, pN3b, or pN3c.
* Prior history of breast cancer, including DCIS (patients with a history of lobular carcinoma in situ \[LCIS\] are eligible).
* Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.
* Prior anthracycline or taxane therapy for any malignancy.
* Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)
* Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen as described in the protocol)
* Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
* Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes:
* Active cardiac disease:
* angina pectoris that requires the use of antianginal medication;
* cardiac arrhythmia requiring medication;
* severe conduction abnormality;
* clinically significant valvular disease;
* cardiomegaly on chest x-ray;
* ventricular hypertrophy on EKG; or
* patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.)
* History of cardiac disease:
* myocardial infarction documented as a clinical diagnosis or by EKG or any other tests;
* documented congestive heart failure; or
* documented cardiomyopathy.
* Psychiatric or addictive disorders that would preclude obtaining informed consent.
* Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.
* Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.
* Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.
* Concurrent treatment with other investigational agents.
* Sensitivity to benzyl alcohol.
* Special conditions for ineligibility of lumpectomy patients: irradiation and surgery. For patients treated by lumpectomy with axillary dissection, breast irradiation is required. Please see guidelines for radiation therapy in Appendix A. In addition, the following patients will also be ineligible:
* Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.
* Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
* Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
NSABP Foundation Inc
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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Comprehensive Cancer Institute
Huntsville, Alabama, United States
Site Status
Providence Alaska Medical Center
Anchorage, Alaska, United States
Site Status
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Site Status
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Site Status
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
Site Status
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States
Site Status
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Site Status
Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach
Long Beach, California, United States
Site Status
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Site Status
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Site Status
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States
Site Status
Sutter Cancer Center
Sacramento, California, United States
Site Status
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Site Status
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Site Status
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Site Status
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
Site Status
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
Site Status
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Site Status
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
Site Status
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Site Status
Morton Plant Hospital
Clearwater, Florida, United States
Site Status
Halifax Medical Center
Daytona Beach, Florida, United States
Site Status
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Site Status
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Site Status
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Site Status
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States
Site Status
Cancer Research Network, Inc.
Plantation, Florida, United States
Site Status
Florida Cancer Specialists
Sarasota, Florida, United States
Site Status
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Site Status
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Site Status
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Site Status
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Site Status
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Site Status
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Site Status
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Site Status
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Site Status
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States
Site Status
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Site Status
CCOP - Central Illinois
Decatur, Illinois, United States
Site Status
CCOP - Evanston
Evanston, Illinois, United States
Site Status
West Suburban Hospital Medical Center
Oak Park, Illinois, United States
Site Status
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Site Status
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Site Status
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
Site Status
Community Hospital
Munster, Indiana, United States
Site Status
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Site Status
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States
Site Status
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Site Status
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Site Status
CCOP - Wichita
Wichita, Kansas, United States
Site Status
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Site Status
Norton Cancer Center at Norton Hospital
Louisville, Kentucky, United States
Site Status
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Site Status
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States
Site Status
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Site Status
CCOP - Ochsner
New Orleans, Louisiana, United States
Site Status
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Site Status
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States
Site Status
National Naval Medical Center
Bethesda, Maryland, United States
Site Status
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Site Status
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Site Status
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States
Site Status
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Site Status
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Site Status
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Site Status
Michigan State University
East Lansing, Michigan, United States
Site Status
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Site Status
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Site Status
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Site Status
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States
Site Status
CCOP - Duluth
Duluth, Minnesota, United States
Site Status
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Site Status
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Site Status
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Site Status
CCOP - Kansas City
Kansas City, Missouri, United States
Site Status
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Site Status
Saint Louis University Cancer Center
St Louis, Missouri, United States
Site Status
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Site Status
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
Site Status
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Site Status
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
Site Status
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Site Status
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Site Status
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Site Status
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Site Status
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Site Status
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Site Status
New York Oncology Hematology, P.C. at Albany Regional Cancer Care
Albany, New York, United States
Site Status
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
Site Status
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, United States
Site Status
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
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Lincoln Medical and Mental Health Center
The Bronx, New York, United States
Site Status
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
Site Status
Alamance Cancer Center
Burlington, North Carolina, United States
Site Status
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Site Status
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States
Site Status
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Site Status
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Site Status
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Site Status
Akron City Hospital at Summa Health System
Akron, Ohio, United States
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Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Site Status
Cancer Center at Jewish Hospital
Cincinnati, Ohio, United States
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Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Site Status
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States
Site Status
South Pointe Hospital Cancer Care Center
Cleveland, Ohio, United States
Site Status
CCOP - Columbus
Columbus, Ohio, United States
Site Status
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
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CCOP - Dayton
Kettering, Ohio, United States
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Cancer Care Center at Northside Medical Center
Youngstown, Ohio, United States
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CCOP - Oklahoma
Tulsa, Oklahoma, United States
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CCOP - Columbia River Oncology Program
Portland, Oregon, United States
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John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States
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Geisinger Medical Center
Danville, Pennsylvania, United States
Site Status
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
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Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
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Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
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Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Site Status
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Site Status
York Cancer Center at Wellspan Health
York, Pennsylvania, United States
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Kent County Memorial Hospital
Warwick, Rhode Island, United States
Site Status
CCOP - Greenville
Greenville, South Carolina, United States
Site Status
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Site Status
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Site Status
Medical City Dallas Hospital
Dallas, Texas, United States
Site Status
Baylor College of Medicine
Houston, Texas, United States
Site Status
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Site Status
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Site Status
CCOP - Scott and White Hospital
Temple, Texas, United States
Site Status
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Site Status
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
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Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Site Status
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Site Status
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Site Status
Puget Sound Oncology Consortium
Seattle, Washington, United States
Site Status
CCOP - Northwest
Tacoma, Washington, United States
Site Status
David Lee Cancer Center at Charleston Area Medical Center
Charleston, West Virginia, United States
Site Status
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
Site Status
St. Vincent Hospital
Green Bay, Wisconsin, United States
Site Status
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Site Status
Oncology Alliance, S.C. - Milwaukee
Milwaukee, Wisconsin, United States
Site Status
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Site Status
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Site Status
Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital
Mississauga, Ontario, Canada
Site Status
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Site Status
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada
Site Status
Montreal General Hospital
Montreal, Quebec, Canada
Site Status
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
Site Status
St. Mary's Hospital Center
Montreal, Quebec, Canada
Site Status
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, Canada
Site Status
Countries
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United States
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84. doi: 10.1056/NEJMoa052122.
Reference Type
RESULT
Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037.
Reference Type
BACKGROUND
Reinholz MM, Dueck AC, Lingle WL, et al.: The concordance between NCCTG's and NSABP's C-myc FISH assays. [Abstract] J Clin Oncol 26 (Suppl 15): A-22110, 2008.
Reference Type
BACKGROUND
Garrison LP Jr, Lubeck D, Lalla D, Paton V, Dueck A, Perez EA. Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer. 2007 Aug 1;110(3):489-98. doi: 10.1002/cncr.22806.
Reference Type
BACKGROUND
Kurian AW, Thompson RN, Gaw AF, Arai S, Ortiz R, Garber AM. A cost-effectiveness analysis of adjuvant trastuzumab regimens in early HER2/neu-positive breast cancer. J Clin Oncol. 2007 Feb 20;25(6):634-41. doi: 10.1200/JCO.2006.06.3081.
Reference Type
BACKGROUND
Liberato NL, Marchetti M, Barosi G. Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2007 Feb 20;25(6):625-33. doi: 10.1200/JCO.2006.06.4220.
Reference Type
BACKGROUND
Perez E, Romond E, Suman V, et al.: Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patiens with HER2-positive breast cancer. [Abstract] J Clin Oncol 25 (Suppl 18): 512, 6s, 2007.
Reference Type
BACKGROUND
Telli ML, Hunt SA, Carlson RW, Guardino AE. Trastuzumab-related cardiotoxicity: calling into question the concept of reversibility. J Clin Oncol. 2007 Aug 10;25(23):3525-33. doi: 10.1200/JCO.2007.11.0106.
Reference Type
BACKGROUND
Baselga J, Perez EA, Pienkowski T, Bell R. Adjuvant trastuzumab: a milestone in the treatment of HER-2-positive early breast cancer. Oncologist. 2006;11 Suppl 1:4-12. doi: 10.1634/theoncologist.11-90001-4.
Reference Type
BACKGROUND
Gupta AK, Mekan SF, Eckman MH: Trastuzumab for all? A decision analysis examining tradeoffs between efficacy and cardiac toxicity of adjuvant therapy in HER2 positive breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-6022, 306s, 2006.
Reference Type
BACKGROUND
Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med. 2005 Oct 20;353(16):1652-4. doi: 10.1056/NEJMp058197. No abstract available.
Reference Type
BACKGROUND
Hortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med. 2005 Oct 20;353(16):1734-6. doi: 10.1056/NEJMe058196. No abstract available.
Reference Type
BACKGROUND
Tan-Chiu E, Piccart M. Moving forward: Herceptin in the adjuvant setting. Oncology. 2002;63 Suppl 1:57-63. doi: 10.1159/000066201.
Reference Type
BACKGROUND
Costa RB, Kurra G, Greenberg L, Geyer CE. Efficacy and cardiac safety of adjuvant trastuzumab-based chemotherapy regimens for HER2-positive early breast cancer. Ann Oncol. 2010 Nov;21(11):2153-2160. doi: 10.1093/annonc/mdq096. Epub 2010 Mar 29.
Reference Type
BACKGROUND
Rastogi P, Jeong J, Geyer CE, et al.: Five year update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)→paclitaxel (T) vs. AC→T with trastuzumab(H). [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA513, 2007.
Reference Type
RESULT
Geyer CE, Bryant JL, Romond EH, et al.: Update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)→paclitaxel (T) vs. AC→T with trastuzumab (H). [Abstract] J Clin Oncol 24 (Suppl 18): A-581, 2006.
Reference Type
RESULT
Kim C, Bryant J, Horne Z, et al.: Trastuzumab sensitivity of breast cancer with co-amplification of HER2 and cMYC suggests pro-apoptotic function of dysregulated cMYC in vivo. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-46, 2005.
Reference Type
RESULT
Tan-Chiu E, Yothers G, Romond E, Geyer CE Jr, Ewer M, Keefe D, Shannon RP, Swain SM, Brown A, Fehrenbacher L, Vogel VG, Seay TE, Rastogi P, Mamounas EP, Wolmark N, Bryant J. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol. 2005 Nov 1;23(31):7811-9. doi: 10.1200/JCO.2005.02.4091.
Reference Type
RESULT
Geyer CE Jr, Bryant J, Romond E: Cardiac safety analysis of the first stage of NSABP B-31, a randomized trial comparing the safety and efficacy of adriamycin® and cyclophosphamide (AC) followed by taxol® to that of AC followed by taxol® plus herceptin® in patients (Pts) with operable, node-positive (N+), HER-2 overexpressing breast cancer (HER2+BC). [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-23, S13, 2003.
Reference Type
RESULT
Paik S, Bryant J, Tan-Chiu E, Romond E, Hiller W, Park K, Brown A, Yothers G, Anderson S, Smith R, Wickerham DL, Wolmark N. Real-world performance of HER2 testing--National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst. 2002 Jun 5;94(11):852-4. doi: 10.1093/jnci/94.11.852.
Reference Type
RESULT
Perez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, Martino S, Mamounas EP, Kaufman PA, Wolmark N. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011 Sep 1;29(25):3366-73. doi: 10.1200/JCO.2011.35.0868. Epub 2011 Jul 18.
Reference Type
RESULT
Chumsri S, Pai T, Ma Y, Li Z, Gil A, Moreno-Aspitia A, Colon-Otero G, Pogue-Geile KL, Rasgoti P, Paik S, Perez EA, Thompson EA. Clinical Treatment Score Post-5 Years (CTS5) and Late Recurrence Risk in Hormone Receptor-Positive, HER2-Positive Breast Cancer. J Natl Compr Canc Netw. 2024 Aug 26;22(7):463-468. doi: 10.6004/jnccn.2024.7015.
Reference Type
DERIVED
Chumsri S, Li Z, Serie DJ, Mashadi-Hossein A, Colon-Otero G, Song N, Pogue-Geile KL, Gavin PG, Paik S, Moreno-Aspitia A, Perez EA, Thompson EA. Incidence of Late Relapses in Patients With HER2-Positive Breast Cancer Receiving Adjuvant Trastuzumab: Combined Analysis of NCCTG N9831 (Alliance) and NRG Oncology/NSABP B-31. J Clin Oncol. 2019 Dec 10;37(35):3425-3435. doi: 10.1200/JCO.19.00443. Epub 2019 Oct 17.
Reference Type
DERIVED
Chumsri S, Serie DJ, Li Z, Pogue-Geile KL, Soyano-Muller AE, Mashadi-Hossein A, Warren S, Lou Y, Colon-Otero G, Knutson KL, Perez EA, Moreno-Aspitia A, Thompson EA. Effects of Age and Immune Landscape on Outcome in HER2-Positive Breast Cancer in the NCCTG N9831 (Alliance) and NSABP B-31 (NRG) Trials. Clin Cancer Res. 2019 Jul 15;25(14):4422-4430. doi: 10.1158/1078-0432.CCR-18-2206. Epub 2019 Feb 26.
Reference Type
DERIVED
Gavin PG, Song N, Kim SR, Lipchik C, Johnson NL, Bandos H, Finnigan M, Rastogi P, Fehrenbacher L, Mamounas EP, Swain SM, Wickerham DL, Geyer CE Jr, Jeong JH, Costantino JP, Wolmark N, Paik S, Pogue-Geile KL. Association of Polymorphisms in FCGR2A and FCGR3A With Degree of Trastuzumab Benefit in the Adjuvant Treatment of ERBB2/HER2-Positive Breast Cancer: Analysis of the NSABP B-31 Trial. JAMA Oncol. 2017 Mar 1;3(3):335-341. doi: 10.1001/jamaoncol.2016.4884.
Reference Type
DERIVED
O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.
Reference Type
DERIVED
Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE Jr, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014 Nov 20;32(33):3744-52. doi: 10.1200/JCO.2014.55.5730. Epub 2014 Oct 20.
Reference Type
DERIVED
Romond EH, Jeong JH, Rastogi P, Swain SM, Geyer CE Jr, Ewer MS, Rathi V, Fehrenbacher L, Brufsky A, Azar CA, Flynn PJ, Zapas JL, Polikoff J, Gross HM, Biggs DD, Atkins JN, Tan-Chiu E, Zheng P, Yothers G, Mamounas EP, Wolmark N. Seven-year follow-up assessment of cardiac function in NSABP B-31, a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with node-positive, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2012 Nov 1;30(31):3792-9. doi: 10.1200/JCO.2011.40.0010. Epub 2012 Sep 17.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000067269
Identifier Type: -
Identifier Source: secondary_id
NSABP B-31
Identifier Type: -
Identifier Source: org_study_id
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