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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00138125 |
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. 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. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: fulvestrant Drug: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Phase II Randomized Trial of Faslodex and Herceptin, Alone and Combined, in the First - Line Treatment of Hormone Receptor-Positive, HER-2/Neu-Overexpressing Metastatic Breast Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | May 2005 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 only in all subsequent courses.
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Drug: fulvestrant
Given IV
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Arm II: Experimental
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22.
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Drug: trastuzumab
Given intramuscularly
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Arm III: Experimental
Patients receive fulvestrant as in arm I in combination with trastuzumab as in arm II.
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Drug: fulvestrant
Given IV
Drug: trastuzumab
Given intramuscularly
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant endocrine therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.
In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 120 patients (40 per treatment arm) will be accrued for this study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast at first diagnosis
HER2/neu-positive disease by fluorescence in situ hybridization
Hormone receptor status:
Estrogen receptor- and/or progesterone receptor-positive tumor by immunohistochemistry
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined by 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent long-term anticoagulant therapy, except antiplatelet therapy (e.g., warfarin)
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 |
Study Chair: | Richard J. Pietras, MD, PhD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000439421, UCLA-0502057-01, TORI-B-04 |
Study First Received: | August 29, 2005 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00138125 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Trastuzumab Fulvestrant |
Breast Neoplasms Breast Diseases Recurrence |
Estrogen Receptor Modulators Estrogen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents |
Hormone Antagonists Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |