Breast Cancer Clinical Trial

Bexarotene in Treating Patients With Metastatic Breast Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to study the effectiveness of bexarotene in treating patients who have metastatic breast cancer.

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Full Description

OBJECTIVES: I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose levels in patients with advanced breast cancer. II. Assess the safety and tolerability of this treatment regimen in this patient population. III. Evaluate the efficacy of oral bexarotene in terms of induction of differentiation and decreased aberrant cell proliferation in these patients.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to prior therapy for metastatic disease. Patients are randomized to one of two dose levels. All patients receive oral bexarotene once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every week for the first month, at weeks 6 and 8, then monthly thereafter.

PROJECTED ACCRUAL: A total of 84-180 patients will be accrued for this study.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer No CNS metastases No rapidly progressing visceral disease Previously irradiated lesions(s) may be designated as measurable indicator tumor(s) only if more than 6 months since radiotherapy, patient has no other measurable disease regrowth, and bidimensionally measurable regrowth is documented within 2 months prior to study Stratum 1 (hormonal): Must be hormone receptor positive (ER or PR) Prior hormonal therapy only allowed for metastatic disease Must have progressed on last hormonal regimen Must have at least one bidimensionally measurable tumor Stratum 2 (chemotherapy): Hormone receptor positive or negative Must have progressed on or after prior chemotherapy (1-2 regimens) for metastatic disease (bone marrow transplant counts as 2 regimens) Prior hormonal therapy allowed Must have at least one bidimensionally measurable tumor Stratum 3 (tamoxifen): Must be hormone receptor positive (ER or PR) and progressing on tamoxifen No symptomatic visceral metastasis if on adjuvant tamoxifen at time of systemic recurrence Must have at least one bidimensionally measurable tumor, or lytic bone lesion which measures at least one cm in diameter Hormone receptor status: See above

PATIENT CHARACTERISTICS: Age: Over 18 Menopausal status: Not specified Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Fasting triglycerides within normal range Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN Concurrent medication with drugs that significantly alter hepatic metabolism (e.g., phenobarbital, phenytoin, oral azole antifungals) allowed only if dosage stable Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 40 mL/min Concurrent medication with drugs that significantly alter renal metabolism (e.g., probenecid) allowed only if dosage stable Other: At least 5 years since any other prior invasive malignancy except basal cell and squamous cell carcinoma of the skin No serious concurrent illness that would prevent compliance No history of or clinically significant risk factors for developing pancreatitis Fasting triglycerides within normal range Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior monoclonal antibody HER2 therapy for metastatic disease allowed only if combined with chemotherapy or hormonal therapy and treatment failed No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy (at least 6 weeks since prior mitomycin or nitrosourea) No prior retinoid therapy for breast cancer At least 3 months since any other prior retinoid therapy except topical application for dermatological indications No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior non-FDA approved hormonal therapy No other concurrent hormonal therapy except chronic low dose hormone replacement therapy or low dose corticosteroids for noncancer indication Radiotherapy: See Disease Characteristics Prior radiotherapy allowed Concurrent radiotherapy allowed only to non-indicator tumor(s) that do not represent new disease or disease progression Surgery: Prior surgery allowed Other: At least one month since prior investigational therapy (except hormonal) No other concurrent investigational therapy Concurrent medication with drugs that significantly alter hepatic metabolism (e.g., phenobarbital, phenytoin, oral azole antifungals) allowed only if dosage stable No more than 15,000 IU of vitamin A consumed daily

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT00003752

Recruitment Status:

Completed

Sponsor:

Ligand Pharmaceuticals

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There are 30 Locations for this study

See Locations Near You

University of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Beckman Research Institute, City of Hope
Los Angeles California, 91010, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington District of Columbia, 20007, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33136, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Louisiana State University School of Medicine
New Orleans Louisiana, 70112, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Michigan State University
East Lansing Michigan, 48824, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
Hematology Oncology Consultants Inc
Columbus Ohio, 43235, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland Oregon, 97201, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville Tennessee, 37203, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Cancer Center, University of Virginia HSC
Charlottesville Virginia, 22908, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT00003752

Recruitment Status:

Completed

Sponsor:


Ligand Pharmaceuticals

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