Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03130439|
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Abemaciclib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer|
|Actual Study Start Date :||May 26, 2017|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2025|
-Abemaciclib will be administered orally, twice daily on days 1 to 28
Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Other Name: LY2835219
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130439
|Contact: Sara Tolaney, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Sara Tolaney, MD, MPH 617-632-3800 email@example.com|
|Principal Investigator: Sara Tolaney, MD, MPH|
|Principal Investigator:||Sara Tolaney, MD, MPH||Dana-Farber Cancer Institute|