Recurrent Breast Carcinoma Clinical Trial
Official title:
A Phase 1 Study With Dose Expansion of Dinaciclib (SCH 727965) in Combination With Epirubicin in Patients With Metastatic Triple Negative Breast Cancer
This phase I clinical trial studies the side effects and the best dose of dinaciclib when given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is designed to stop cancer cells from dividing into new cancer cells. Epirubicin is designed to block the way cancer cells grow and divide and may slow or stop cancer cells from spreading throughout the body. Researchers want to find out what is the highest tolerable dose of the experimental drug dinaciclib that can be given in combination with epirubicin in patients with metastatic triple negative breast cancer.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of dinaciclib given in combination with
epirubicin in patients with metastatic triple negative breast cancer.
SECONDARY OBJECTIVES:
I. To determine the predictive value of myeloid cell leukemia sequence 1 protein (MCL-1), low
molecular weight cyclin E (LMW-E), and tumor grade as predictors of biologic response (i.e.
induction of apoptosis) in tumors treated with therapy.
II. To evaluate the efficacy of combination therapy. III. To determine the effects of therapy
on proliferation as measured by proliferation-related Ki-67 antigen (Ki67) and apoptosis as
measured by terminal deoxynucleotidyl transferase (TdT)-mediated dUTP nick end labeling assay
(TUNEL).
OUTLINE: This is a dose-escalation study of dinaciclib.
Patients receive dinaciclib intravenously (IV) over 2 hours on day 1 and epirubicin
hydrochloride IV over 30 minutes on day 2. Treatment repeats every 21 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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