Study on Ribociclib and Bicalutamide for Advanced AR+ Triple-Negative Breast Cancer

Sponsor: Kari Wisinski

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03090165

Provider View

This clinical trial is testing a combination of two drugs, ribociclib and bicalutamide, to see if they can help treat advanced triple-negative breast cancer that has androgen receptors (AR+ TNBC).

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced triple-negative breast cancer that has androgen receptors (AR+ TNBC). The trial involves taking two drugs, ribociclib and bicalutamide, to see if they can work together to treat this type of cancer. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it is conducted at multiple locations. Participants will take bicalutamide daily and ribociclib in increasing doses to find the best dose for future studies.

Description

This clinical trial is designed to test the safety and effectiveness of combining two drugs, ribociclib and bicalutamide, for treating advanced triple-negative breast cancer with androgen receptors (AR+ TNBC). The study is divided into two parts: Phase I and Phase II.

In Phase I, participants will receive bicalutamide daily and ribociclib in increasing doses to determine the safest and most effective dose. Each treatment cycle lasts 28 days. In Phase II, participants will start with bicalutamide alone for two weeks before adding ribociclib to the treatment. This phase aims to further evaluate the combination's effectiveness.

Participants will be closely monitored for any side effects and the overall response to the treatment. The study does not involve randomization or blinding, meaning all participants receive the same treatment, and both the researchers and participants know what treatment is being given.

Eligibility Criteria

Exclusion Criteria

  • Previous treatment with AR antagonists like bicalutamide or CDK 4/6 inhibitors, except in certain early-stage breast cancer studies.
  • Active infection needing treatment.
  • Pregnant or breastfeeding women.
  • Other active cancers needing treatment, except for certain skin or cervical cancers.
  • Recent use of investigational drugs or certain therapies.
  • Recent major surgery or unresolved side effects from surgery.
  • Allergies to ribociclib or bicalutamide.
  • Digestive issues affecting drug absorption.
  • History of HIV infection.
  • Severe medical conditions that pose safety risks.
  • Serious wounds or recent heart or blood vessel issues.
  • Heart conditions like long QT syndrome or certain arrhythmias.
  • High or low blood pressure at screening.
  • Use of certain medications affecting the heart or liver.
  • Use of certain herbal supplements or grapefruit products before the study.

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