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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Southwest Oncology Group Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004125 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer |
Study Start Date: | October 1999 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs breast conservation surgery). Patients are randomized to one of four treatment arms.
After completion of all chemotherapy, patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigator's discretion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0)
Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection)
Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Joseph A. Sparano, MD | Albert Einstein College of Medicine of Yeshiva University |
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
Study Chair: | Vicky E. Jones, MD | University of California, San Diego |
Study ID Numbers: | CDR0000067353, E-1199, CLB-49906, NCCTG-E1199, SWOG-E1199 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004125 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 Docetaxel 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 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 Docetaxel 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 Doxorubicin Pharmacologic Actions Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists |