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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006110 |
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. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV 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: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Nonrandomized Phase II Study of Multimodality Therapy for Stage IIB, IIIA/B, or Initially Presenting Stage IV Breast Cancer With Four Cycles of AC Followed by 12 Weeks of Single Agent Paciltaxel With or Without Herceptin Followed by Local Therapy Followed by Weekly Herceptin or No Additional Therapy |
Study Start Date: | December 1998 |
OBJECTIVES:
OUTLINE: Patients are assigned to receive either neoadjuvant therapy (HER-2 overexpressing and nonoverexpressing patients) or adjuvant therapy (HER-2 overexpressing patients only).
Neoadjuvant therapy: Patients assigned to receive neoadjuvant therapy receive one of two treatment regimens.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 125 patients (100 in the neoadjuvant group and 25 in the adjuvant group) will be accrued for this study within 5 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast
Any of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other prior malignancies except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7305 |
Study Chair: | Lisa A. Carey, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068121, UNC-9818, NCI-G00-1836 |
Study First Received: | August 3, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006110 |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IV breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer inflammatory breast cancer |
Skin Diseases Citric Acid Breast Neoplasms Cyclophosphamide Tamoxifen Doxorubicin Antibodies, Monoclonal |
Inflammatory breast cancer Antibodies Paclitaxel Trastuzumab Breast Diseases Immunoglobulins |
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 |