Study on Abemaciclib and Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05095207

Provider View

This clinical trial is testing a combination of two drugs, Abemaciclib and Bicalutamide, to see if they can effectively treat a specific type of metastatic breast cancer that is positive for androgen receptors and negative for HER2.

Patient Parameters

Program Overview

This study is exploring the use of Abemaciclib and Bicalutamide together to treat patients with a type of breast cancer that has spread to other parts of the body and is positive for androgen receptors but negative for HER2. The trial aims to find the best dose and assess how well the treatment works and how safe it is. About 54-60 patients will participate over three years, receiving the treatment until their cancer progresses.

Description

This clinical trial is investigating a new treatment for a specific type of metastatic breast cancer that is positive for androgen receptors and negative for HER2. The study involves using two drugs, Abemaciclib and Bicalutamide, to see if they can work together to improve treatment outcomes. Researchers believe that this combination could be more effective than using either drug alone, especially for patients who have already tried other hormone therapies. The treatment is taken orally every day, which is convenient for patients, and is expected to have manageable side effects.

The main goals of the study are to determine the best dose of Abemaciclib when used with Bicalutamide, to evaluate the treatment's effectiveness, and to monitor its safety and tolerability. Participants will continue the treatment until their cancer shows signs of progression. The study will also look at how long patients can live without their cancer getting worse.

Participants will be closely monitored throughout the study, with regular check-ups and tests to assess their health and the treatment's impact on their cancer. The study aims to provide valuable insights into whether this combination therapy can offer a new treatment option for patients with this type of breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 years or older.
  • Have a confirmed diagnosis of HER2-negative breast cancer that has returned, cannot be surgically removed, or has spread to other parts of the body.
  • Cancer must be positive for androgen receptors (AR+).
  • Have a performance status score of 0 to 2, indicating good overall health.
  • If the cancer is also positive for estrogen or progesterone receptors, must have had at least one prior hormone therapy for metastatic cancer.
  • If the cancer is triple-negative (ER-, PR-, HER2-), may have had up to four prior chemotherapy treatments for metastatic cancer.
  • Must have recovered from any previous chemotherapy or radiation therapy.
  • Must be post-menopausal or receiving treatment to suppress ovarian function.
  • Must have a negative pregnancy test before starting treatment.
  • Must agree to use effective contraception during the study and for three weeks after treatment ends.

Exclusion Criteria

  • Have received any investigational drugs or treatments within 28 days before starting the study.
  • Have had major surgery within four weeks before starting the study.
  • Have untreated or unstable brain or spinal cord cancer spread.
  • Are currently using hormone therapy or certain other medications.
  • Have severe or uncontrolled medical conditions, including certain heart problems or infections.
  • Have a history of severe allergic reactions to the study drugs.
  • Are pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Have other active cancers or have had certain other cancers within the past three years.

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