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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group Southwest Oncology Group National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024102 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: CMF regimen Drug: capecitabine Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: methotrexate Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer |
Estimated Enrollment: | 1800 |
Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (65 to 69 vs 70 to 80 vs over 80), performance status (0-1 vs 2), and HER2 status (postive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients with insufficient left ventricular ejection fraction (LVEF) are assigned to group A. Patients with normal LVEF are assigned to group A or B based on physician/patient choice.
Beginning within 12 weeks after treatment in arm I or II, patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor daily for 5 years.
Beginning 4-6 weeks after treatment in arm I or II, eligible patients who previously underwent breast conservation surgery undergo radiotherapy.
Quality of life is assessed at baseline; at 6 weeks (group B), 9 weeks (arm II), or 12 weeks (group A); and then at 1, 12, 18, and 24 months after study.
Drug adherence is assessed at 9 weeks during study (arm II).
Patients are followed at 1 month, every 6 months for 2 years, and then annually for 15 years.
PROJECTED ACCRUAL: A total of 600-1,800 patients (300-900 per treatment arm) will be accrued for this study within 2-6 years.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven operable adenocarcinoma of the breast*
Stage I-IIIC disease
Must have undergone 1 of the following within the past 12 weeks:
Modified radical mastectomy
No evidence of gross or microscopic invasive tumor at the surgical resection margins
Lumpectomy (clear margins preferred)
Any number of previously excised nodes allowed
HER2/neu positive, negative, or unknown
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other concurrent active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Hyman B. Muss, MD | Fletcher Allen Health Care - University Health Center Campus |
Study Chair: | Antonio C. Wolff, MD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Julie R. Gralow, MD | Seattle Cancer Care Alliance |
Study Chair: | Debjani Grenier, MD | CancerCare Manitoba |
Study ID Numbers: | CDR0000068891, CALGB-49907, ECOG-CALGB-49907, CAN-NCIC-MAC1, SWOG-CALGB-49907 |
Study First Received: | September 13, 2001 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00024102 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Folic Acid Capecitabine Skin Diseases Fluorouracil Methotrexate |
Breast Neoplasms Cyclophosphamide Doxorubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |