Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00087178
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.
- Detailed Description
OBJECTIVES:
Primary
* Compare disease-free survival of women with node-negative breast cancer treated with adjuvant fluorouracil, epirubicin, and cyclophosphamide vs doxorubicin and cyclophosphamide.
Secondary
* Compare survival, recurrence-free interval, and distant recurrence-free interval in patients treated with these regimens.
* Compare adverse events in patients treated with these regimens.
* Compare quality of life, with regard to physical functioning, vitality, symptoms, and rates of post-chemotherapy amenorrhea, in premenopausal patients treated with these regimens.
* Determine the effect of induction of post-chemotherapy amenorrhea on disease-free survival in premenopausal patients treated with these regimens.
* Correlate post-chemotherapy amenorrhea and disease-free survival with hormone receptor status in premenopausal patients treated with these regimens.
* Correlate changes in left ventricular ejection fraction (LVEF) with self-reported physical functioning in patients treated with these regimens.
* Compare the efficacy of these regimens in patients with Human Epidermal Growth Factor Receptor 2 (HER2)/neu and/or topoisomerase-2-alpha gene amplification.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor \[ER\] positive or progesterone receptor \[PR\] positive vs ER negative or PR negative) and type of prior surgery (lumpectomy vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
* Arm 1: Patients receive doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
* Arm 2: Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
All patients with ER- or PR-positive tumors receive hormonal therapy daily beginning within 3-12 weeks after the completion of chemotherapy and continuing for at least 5 years.
All patients who have undergone prior lumpectomy undergo whole-breast radiotherapy beginning as soon as possible after the completion of chemotherapy. Patients who have undergone prior total mastectomy may undergo chest wall radiotherapy at the investigator's discretion. Patients assigned to the partial breast irradiation (PBI) group of protocol NSABP-B-39 undergo PBI according to protocol-specific guidelines.
Quality of life is assessed at baseline, on day 1 of course 4 of chemotherapy, and then every 6 months for 3 years.
Patients are followed every 6 months for up to 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,700 patients (1,350 per treatment arm) will be accrued for this study within 3.75 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2722
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: adriamycin + cyclophosphamide cyclophosphamide Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Arm 1: adriamycin + cyclophosphamide adriamycin Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Arm 2: fluorouracil + epirubicin + cyclophosphamide cyclophosphamide Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Arm 2: fluorouracil + epirubicin + cyclophosphamide epirubicin Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Arm 2: fluorouracil + epirubicin + cyclophosphamide fluorouracil Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
- Primary Outcome Measures
Name Time Method Disease Free Survival 9 years Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer
- Secondary Outcome Measures
Name Time Method HER-2 and Topo II Gene Amplification 6 years Recurrence-free Interval 9 years Percentage of patients with local-regional recurrence or distant recurrence
Distant Recurrence-free Interval 9 years Percentage of patients with distant recurrence
Survival 9 years Percentage of patients alive
Adverse Events 9 years Percentage of patients with at least one grade 2 or higher adverse event reported
Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation 12 months Change in LVEF from randomization to 12 months
Quality of Life-Functional Assessment of Cancer Therapy 12 months Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL.
Post Chemotherapy Amenorrhea 18 months Percent with post chemotherapy amenorrhea
Trial Locations
- Locations (602)
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
Banner Thunderbird Medical Center
🇺🇸Glendale, Arizona, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Scroll for more (592 remaining)Clearview Cancer Institute🇺🇸Huntsville, Alabama, United States