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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301899 |
RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, 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 trastuzumab together with pertuzumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with pertuzumab works in treating patients with unresectable locally advanced or metastatic breast cancer that did not respond to previous trastuzumab.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: pertuzumab Drug: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study to Evaluate the Efficacy and Safety Using Combined Monoclonal Antibodies, Trastuzumab and Pertuzumab in Subjects With Her-2 Overexpressed Locally Advanced and Metastatic Breast Cancer |
Estimated Enrollment: | 37 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1 and pertuzumab IV over 30-60 minutes on day 2 of course 1. Beginning in course 2 and for all subsequent courses, patients receive both trastuzumab and pertuzumab on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer of 1 of the following stages:
Inoperable locally advanced disease
Disease progression on or after trastuzumab (Herceptin®) based-therapy
No clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT scan or MRI
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Chia Portera, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000462639, NCI-06-C-0035, NCI-P6660 |
Study First Received: | March 9, 2006 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00301899 |
Health Authority: | United States: Food and Drug Administration |
recurrent breast cancer male breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Antibodies, Monoclonal Antibodies Skin Diseases Breast Neoplasms, Male Trastuzumab |
Breast Neoplasms Breast Diseases Recurrence Immunoglobulins |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |