Clinical Trial: Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

Brief Summary: This research study is studying a drug called Abemaciclib as a possible treatment for have metastatic triple-negative type of breast cancer.

Detailed Summary:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved abemaciclib as a treatment for any disease.

Some triple-negative breast cancers show expression of the Rb protein and are referred to as "Rb-positive." The Rb protein is important because it controls the way that cancer cells divide and grow. Drugs like abemaciclib work by changing the way that Rb functions. This can potentially stop cancer cells from dividing, and can also potentially lead to cancer cell death.

In this research study, the investigators are are looking to see how safe abemaciclib is and how well it will work to help people with triple-negative breast cancer that is Rb-positive.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Objective Response Rate [ Time Frame: 2 years ]

ORR as confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival [ Time Frame: 2 years ]
  • Overall Survival [ Time Frame: 2 years ]
  • Disease Control Rate [ Time Frame: 2 years ]
  • Clinical Benefit Rate [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: April 24, 2017
Date Started: May 31, 2017
Date Completion: November 30, 2024
Last Updated: April 26, 2017
Last Verified: April 2017