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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003088 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer |
Estimated Enrollment: | 2000 |
Study Start Date: | September 1997 |
OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Arm I: Patients receive sequential chemotherapy every 3 weeks. Doxorubicin IV is administered once every 3 weeks for 4 doses. Paclitaxel IV is then administered over 3 hours once every 3 weeks for 4 doses. Cyclophosphamide IV is administered once every 3 weeks for 4 doses following paclitaxel. Arm II: Patients receive sequential chemotherapy every 2 weeks. Doxorubicin IV is administered once every 2 weeks for 4 doses. Paclitaxel IV is then administered over 3 hours once every 2 weeks for 4 doses. Cyclophosphamide IV is administered once every 2 weeks for 4 doses following paclitaxel. Filgrastim (G-CSF) is administered by subcutaneous injection on days 3-10 after each dose of doxorubicin, paclitaxel, and cyclophosphamide. Arm III: Patients receive combination chemotherapy every 3 weeks. Combination doxorubicin IV and cyclophosphamide IV is administered once every 3 weeks for 4 doses.
Paclitaxel IV is administered over 3 hours once every 3 weeks for 4 doses following combination chemotherapy. Arm IV: Patients receive combination chemotherapy every 2 weeks. Combination doxorubicin IV and cyclophosphamide IV is administered once every 2 weeks for 4 doses. Paclitaxel IV is administered over 3 hours once every 2 weeks for 4 doses following combination chemotherapy. G-CSF is administered by subcutaneous injection on days 3-10 after each dose of doxorubicin/cyclophophamide and after each dose of paclitaxel. After completion of all chemotherapy, patients receive tamoxifen orally for 5 years. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study within 22 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically diagnosed operable, stage II or IIIA adenocarcinoma of the breast One or more positive lymph nodes (T0-3, N1-2, and M0) Metaplastic carcinoma allowed Bilateral breast cancer allowed No metastatic disease Not locally advanced and no tumors fixed to the chest wall, peau d'orange skin changes, skin ulcerations, or clinical inflammatory changes Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within upper limits of normal Renal: Not specified Cardiovascular: No uncontrolled or severe cardiovascular disease No myocardial infarction within 6 months No congestive heart failure Other: No other serious medical illness No psychoses No active uncontrolled bacterial, viral, or fungal infection HIV negative Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No greater than 4 weeks of prior tamoxifen therapy for malignancy No concurrent tamoxifen therapy Radiotherapy: No prior radiation therapy for this malignancy Surgery: No greater than 84 days since prior mastectomy or axillary dissection
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 10309-1016 | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Louisiana | |
CCOP - Ochsner | |
New Orleans, Louisiana, United States, 70121 | |
United States, Michigan | |
CCOP - Ann Arbor Regional | |
Ann Arbor, Michigan, United States, 48106 | |
United States, Minnesota | |
CCOP - Duluth | |
Duluth, Minnesota, United States, 55805 | |
CentraCare Clinic | |
Saint Cloud, Minnesota, United States, 56303 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68131 | |
United States, North Dakota | |
Altru Health Systems | |
Grand Forks, North Dakota, United States, 58201 | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
Quain & Ramstad Clinic, P.C. | |
Bismarck, North Dakota, United States, 58501 | |
United States, Ohio | |
CCOP - Toledo Community Hospital Oncology Program | |
Toledo, Ohio, United States, 43623-3456 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57105-1080 | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 | |
Canada, Saskatchewan | |
Saskatchewan Cancer Agency | |
Regina, Saskatchewan, Canada, S4S 6X3 |
Study Chair: | Marc L. Citron, MD | ProHEALTH Care Associates, LLP - Lake Success |
Study Chair: | James N. Ingle, MD | Mayo Clinic |
Study Chair: | Nancy E. Davidson, MD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Silvana Martino, DO | Van Nuys Breast Center |
Study ID Numbers: | CDR0000065788, CLB-9741, E-C9741, NCCTG-C9741, SWOG-C9741 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003088 History of Changes |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IIIA breast cancer |
Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators Hormones Anti-Bacterial Agents Estrogen Receptor Modulators Alkylating Agents Breast Diseases Estrogens Estrogen Antagonists Skin Diseases |
Antineoplastic Agents, Hormonal Citric Acid Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Tamoxifen Doxorubicin Paclitaxel Tubulin Modulators Citrate Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Antibiotics, Antineoplastic Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases |
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Mitosis Modulators Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Tamoxifen Pharmacologic Actions Doxorubicin Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating |