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| Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006110 |
Purpose
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 |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000068121, UNC-9818, NCI-G00-1836 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006110 History of Changes |
| 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 |
|
Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators Hormones Antibodies, Monoclonal Anti-Bacterial Agents Estrogen Receptor Modulators Inflammatory Breast Cancer Trastuzumab Alkylating Agents Breast Diseases Immunoglobulins |
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Citric Acid Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Tamoxifen Immunosuppressive Agents Doxorubicin Antibodies Paclitaxel Tubulin Modulators Citrate |
|
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 Trastuzumab 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 |