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Study 5 of 752 for search of: | United States, South Dakota |
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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390455 |
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. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: fulvestrant Drug: lapatinib ditosylate Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control |
Official Title: | Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer |
Estimated Enrollment: | 324 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral lapatinib ditosylate once daily on days 1-28 and fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of each subsequent course.
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Drug: fulvestrant
Given intramuscularly
Drug: lapatinib ditosylate
Given orally
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Arm II: Active Comparator
Patients receive oral placebo once daily on days 1-28 and fulvestrant as in arm I.
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Drug: fulvestrant
Given intramuscularly
Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, randomized, double-blind, placebo-controlled study. Patients are stratified according to prior tamoxifen citrate therapy (yes vs no) and bone disease only (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then on day 1 of every 2 courses of treatment (i.e., day 1 of courses 3, 5, 7, etc.).
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* or cytologically confirmed breast cancer, meeting 1 of the following stage criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
The following are not considered measurable disease:
Must have received prior therapy with 1 or 2 endocrine treatments for breast cancer in either the adjuvant or metastatic setting (not including treatment for ovarian suppression or amenorrhea)
No symptomatic brain or other CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Postmenopausal, meeting 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior chemotherapy and recovered
At least 3 weeks since prior trastuzumab (Herceptin®) and recovered
No other concurrent hormonal therapy* except for the following:
No concurrent therapeutic systemic anticoagulation (defined as maintaining INR > 1.6)
Study Chair: | Harold J. Burstein, MD, PhD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000510452, CALGB-40302 |
Study First Received: | October 18, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00390455 |
Health Authority: | Unspecified |
recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Skin Diseases Fulvestrant Breast Neoplasms |
Lapatinib Breast Diseases Recurrence |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |