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Protocol No. UW16044

Principal Investigator ORegan, Ruth

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry; Institutional

Title A phase I/II, single arm, non-randomized study of ribociclib (LEE011), a CDK 4/6 inhibitor in combination with bicalutamide, an androgen receptor (AR) inhibitor, in advanced AR+ triple-negative breast cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-024

Objective This study is being done to find the safe dose of ribociclib combined with bicalutamide and to find out if the combination has any effect on triple negative breast cancer.

Treatment Triple-negative breast cancer is usually treated by combining therapies such as surgery, radiation therapy, and chemotherapy. Since your tumor does not have the three common breast cancer receptors, (estrogen, progesterone, HER-2), researchers are looking for other receptors to block. Androgen receptor (AR) is expressed in some triple negative breast cancer tumors. Researchers will use an AR blocker called bicalutamide in this trial. Ribociclib is an enzyme inhibitor that acts as a "brake" to interrupt and slow or stop the growth of cancer cells. Ribociclib may also help prevent resistance to the androgen receptor therapy. Researchers think that combining ribociclib and bicalutamide will have more benefits than giving either drug on its own.

Description This study will have two parts. The first part (Phase I) will help researchers find the maximum safe dose of ribociclib using a dose escalation plan. In the second part (Phase II) all participants will receive the same dose of ribociclib and bicalutamide. The patients in both groups will take the study drugs by mouth at the same time each morning. In both parts of the study you will receive the study drugs until your cancer gets worse or you have severe side effects.

Key Eligibility
  • Metastatic or unresectable AR+(androgen receptor positive) triple-negative breast cancer (TNBC)
  • No active central nervous system (CNS) metastatic disease
  • Patients may not have had prior therapy with any CDK 4/6 inhibitors
  • Patients may not have had prior therapy with an androgen receptor antagonist
  • Patients can not be pregnant or breastfeeding
  • Patients may not have a known history of HIV infection
  • Patients may not be receiving systemic corticosteroids
  • Patients may not be currently receiving warfarin or other coumarin-derived anticoagulant treatment, prophylaxis or otherwise

Applicable Disease Sites Breast

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park