Breast Cancer Clinical Trial
Official title:
A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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