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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00390455 |
Purpose
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 |
|---|---|---|
|
Breast Cancer |
Drug: fulvestrant Drug: lapatinib ditosylate Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Arm I
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.
|
Drug: fulvestrant
Given intramuscularly
Drug: lapatinib ditosylate
Given orally
|
|
Active Comparator: Arm II
Patients receive oral placebo once daily on days 1-28 and fulvestrant as in arm I.
|
Drug: fulvestrant
Given intramuscularly
Other: placebo
Given orally
|
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.
Eligibility| 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)
Contacts and Locations
Show 148 Study Locations| Study Chair: | Harold J. Burstein, MD, PhD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00390455 History of Changes |
| Other Study ID Numbers: | CDR0000510452, CALGB-40302 |
| Study First Received: | October 18, 2006 |
| Last Updated: | July 31, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Lapatinib Estradiol Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Estrogens Hormones Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |