CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer (LEADER)
|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: NCT03285412|
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : May 14, 2021
This research study is studying a drug as a possible treatment for ER-positive Breast Cancer
The drug involved in this study is:
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Ribociclib Other: Endocrine therapy||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
This research study is a study with endocrine therapy and CDK 4/6 inhibitor (ribociclib) for early breast cancer. There is no placebo in this study. The study has two components - pre-screening with ctDNA to detect minimal residual disease (pre-screening), and treatment with ribociclib in combination with endocrine therapy (main portion).
The FDA (the U.S. Food and Drug Administration) has approved ribociclib in combination with aromatase inhibitors as a treatment option for advanced/metastatic (stage IV) breast cancer.
In this research study, the investigators are evaluating efficacy of ribociclib in patients who have MRD based on ctDNA.
Ribociclib is a drug designed to block certain proteins called cyclin-dependent protein kinases 4 and 6 (CDK4/6). These proteins are needed for cells to divide and may also control the ability of certain cancers to grow. The investigators believe that ribociclib may stop the participant cancer cells from growing and dividing by blocking these CDK4/6 proteins.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER).|
|Actual Study Start Date :||December 12, 2017|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2024|
Experimental: Ribociclib + Endocrine Rx
Ribociclib will be administered. Endocrine therapy will be administered.
Ribociclib is a drug designed to block certain proteins called cyclin-dependent protein kinases 4 and 6 (CDK4/6). These proteins are needed for cells to divide and may also control the ability of certain cancers to grow.
Other Name: Kisqali
Other: Endocrine therapy
Active Comparator: Endocrine Rx
Endocrine therapy will be administered.
Other: Endocrine therapy
- ctDNA clearance [ Time Frame: 12 Months ]tumor ctDNA response after 12 cycles of adjuvant ribociclib in combination with endocrine therapy vs endocrine therapy alone in patients with localized post-menopausal breast cancer and elevated ctDNA.
- Comparison of Adverse Events [ Time Frame: 2 years ]compare the adverse effects, as assessed by CTCAE grading, in patients treated with endocrine therapy within 5 years versus those on endocrine therapy > 5 years
- Number of participants who have a switch in endocrine therapy [ Time Frame: 2 years ]determine how many patients have switch in endocrine therapy
- Disease-free survival (DFS) [ Time Frame: 2 years ]Disease-Free Survival (PFS) is defined as the time from randomization (or registration) to evidence of disease recurrence or death due to any cause. Participants alive without disease recurrence are censored at date of last evaluation.
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): NCT03285412
|Contact: Aditya Bardiafirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Aditya Bardia, MD, MPH 617-724-4000 Bardia.Aditya@mgh.harvard.edu|
|Principal Investigator: Aditya Bardia, MD, MPH|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Jaymin Patel, MD 617-667-2100|
|Principal Investigator: Jaymin Patel, MD|
|Mass General/North Shore Cancer Center||Recruiting|
|Danvers, Massachusetts, United States, 01923|
|Contact: Therese Mulvey, MD 978-882-6060 TMMULVEY@PARTNERS.ORG|
|Principal Investigator: Therese Mulvey, MD|
|Principal Investigator:||Aditya Bardia, MD MPH||Massachusetts General Hospital|