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Sponsors and Collaborators: |
National Cancer Institute of Canada North Central Cancer Treatment Group Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014222 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as epoetin alfa and filgrastim may decrease the side effects of chemotherapy. It is not yet known which treatment regimen is most effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: epoetin alfa Drug: filgrastim Drug: fluorouracil Drug: paclitaxel Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery For Node Positive Or High Risk Node Negative Breast Cancer |
Study Start Date: | December 2000 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs 4-10 vs more than 10), type of prior surgery (total vs partial mastectomy), and estrogen receptor status (positive vs negative). Patients are randomized to one of three treatment arms.
Beginning 21 days after completion of epirubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and G-CSF and epoetin alfa as above. Treatment repeats every 21 days for 4 courses.
Beginning 21 days after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel as in arm II.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
All receptor positive patients receive oral tamoxifen or anastrozole (if tamoxifen is contraindicated) for 5 years after completion of chemotherapy.
Quality of life is assessed at baseline, weeks 4, 8, 12, and 20 (arm I), weeks 4, 8, 13, and 22 (arm II), weeks 3, 9, 12, and 21 (arm III), 9 months, 12 months, and then annually thereafter.
Patients are followed at 9 months, 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,100 patients (700 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | up to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast that is potentially curable
Previously treated with one of the following:
Axillary node positive
Negative nodes allowed if the tumor is ≥ 1 cm and 1 of the following criteria defining high-risk node-negative disease are met:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent pegfilgrastim or darbepoetin alfa (Arm II)
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Mark N. Levine, MD | Margaret and Charles Juravinski Cancer Centre |
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Investigator: | Kathy S. Albain, MD | Loyola University |
Study ID Numbers: | CDR0000068520, CAN-NCIC-MA21, AMGEN-CAN-NCIC-MA21, NCCTG-CAN-NCIC-MA21, BMS-CAN-NCIC-MA21, JANSSEN-ORTHO-CAN-NCIC-MA21, PFIZER-CAN-NCIC-MA21, SWOG-CAN-NCIC-MA21 |
Study First Received: | April 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00014222 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Epoetin Alfa Skin Diseases Paclitaxel Fluorouracil Breast Neoplasms |
Cyclophosphamide Epirubicin Doxorubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Hematinics Antineoplastic Agents Mitosis Modulators Hematologic Agents Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |