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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Southwest Oncology Group National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005970 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Drug: trastuzumab Procedure: adjuvant therapy Procedure: aromatase inhibition therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing Node Positive or High-Risk Node Negative Breast Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed operable adenocarcinoma of the breast, meeting 1 of the following criteria:
Node-positive disease, meeting the following criteria:
High-risk node-negative disease, meeting the following criteria:
Node-negative as determined by 1 of the following:
HER-2 positive
No locally advanced (T4) tumors at diagnosis, including:
No bilateral invasive carcinoma or DCIS (metachronous or synchronous)
No more than 84 days since prior mastectomy or axillary or sentinel node dissection
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other prior malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Study Chair: | Nancy E. Davidson, MD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Peter A. Kaufman, MD | Norris Cotton Cancer Center |
Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
Study ID Numbers: | CDR0000067953, NCCTG-N9831, CALGB-49909, ECOG-N9831, SWOG-N9831, GUMC-00224, CAN-NCIC-MA28 |
Study First Received: | July 5, 2000 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00005970 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Paclitaxel Citric Acid Trastuzumab Breast Neoplasms |
Cyclophosphamide Tamoxifen Doxorubicin Breast Diseases |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Antibiotics, Antineoplastic Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Therapeutic Uses Alkylating Agents |
Estrogen Antagonists Antineoplastic Agents, Hormonal Mitosis Modulators Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |