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Sponsored by: |
Instituto Nacional de Cancerologia |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00533936 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether trastuzumab is more effective than observation when given after combination chemotherapy and trastuzumab in treating patients with breast cancer.
PURPOSE: This randomized phase II trial is studying trastuzumab to see how well it works compared with observation when given after combination chemotherapy and trastuzumab in treating patients undergoing surgery for stage II or stage III breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab |
Estimated Enrollment: | 160 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I :
NOTE: *Patients with initial tumor > 5 cm, inflammatory breast cancer, or with a skin condition or final pathological evaluation of metastasis to > 4 nodes or 1-3 nodes with capsular ruptures or extension to fatty tissues receive adjuvant radiotherapy.
Adjuvant therapy: Beginning 4 weeks after surgery, patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 13 courses.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year thereafter.
PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer by needle biopsy
HER2/neu-positive disease, as evidenced by either of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Mexico, Distrito Federal | |
Hospital General de Mexico | Recruiting |
Mexico City, Distrito Federal, Mexico, C.P. 06726 | |
Contact: Contact Person 52-55-5999-6133 | |
Instituto Nacional de Cancerologia | Recruiting |
Mexico City, Distrito Federal, Mexico, 14000 | |
Contact: Claudia Arce-Salinas, MD 52-55-5628-0400 |
Principal Investigator: | Claudia Arce-Salinas, MD | Instituto Nacional de Cancerologia |
Study ID Numbers: | CDR0000557417, MEX-INC-INCAN-CC-09506 |
Study First Received: | September 20, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00533936 History of Changes |
Health Authority: | Unspecified |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Doxorubicin Anti-Bacterial Agents |
Paclitaxel Fluorouracil Tubulin Modulators Trastuzumab Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Trastuzumab Alkylating Agents Breast Diseases Skin Diseases Mitosis Modulators |
Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |