Palbociclib With Everolimus + Exemestane In BC
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|ClinicalTrials.gov Identifier: NCT02871791|
Recruitment Status : Active, not recruiting
First Posted : August 18, 2016
Last Update Posted : April 28, 2020
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and HER2-negative.
The names of the study interventions involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Hormone Receptor (HR)-Positive Breast Cancer||Drug: Palbociclib Drug: Everolimus Drug: Exemestane||Phase 1 Phase 2|
This is a Phase I/II clinical trial. The Phase I portion of this clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. The Phase II portion of the study tests 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 the combination of Palbociclib, Everolimus, and Exemestane as a treatment for any disease.
This is the first time that the combination of Palbociclib, Everolimus, and Exemestane will be given to humans.
Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions occur in the body), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps, which is known to regulate cell growth. Laboratory testing has suggested Palbociclib may stop the growth of HR+ breast cancer.
Everolimus is a type of drug called an mTORinhibitor that treats breast cancer by preventing the cells from multiplying by inhibiting the pathway, or a sequence of steps, known to regulate cell reproduction. Everolimus also may stop the growth of cancer cells by decreasing blood supply to the cancer cells.
Exemestane is an anti-hormone therapy that prevents breast cancer cell growth by blocking estrogen receptor stimulation. Premenopausal women will also receive an injection drug called an LHRH (luteinizing hormone-releasing hormone) agonist to shut down ovary function. It is standard of care for people with breast cancer, specifically with HR+ breast cancer, to take anti-hormone therapy.
The combination of everolimus and exemestane is FDA approved to treat this type of breast cancer.
The purpose of the Phase I portion of this research study is to determine a safe and tolerable dose of the combination of Palbociclib, Everolimus, and Exemestane for participants with ER-positive, HER2-negative advanced breast cancer.
The purpose of the Phase II portion of this research study is to determine whether the combination of Palbociclib, Everolimus, and Exemestane is an effective treatment for participants with ER-positive, HER2-negative advanced breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer|
|Actual Study Start Date :||August 24, 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Palbociclib, Everolimus, Exemestane
Participants will be treated with increasing/decreasing doses of palbociclib and everolimus to establish MTD(s)/RP2D for both drugs in the setting of the triple combination of palbociclib, everolimus and exemestane
- Number of participants with Dose-Limiting Toxicities (DLT) [ Time Frame: Baseline to 28 Days (1 cycle) ]first cycle DLTs in order to determine maximum tolerated dose of the combination of palbociclib, everolimus and exemestane.
- Clinical Benefit Rate [ Time Frame: 2 Years ]
- Overall Response Rate [ Time Frame: 2 Years ]Response will be assessed among participants eligible for the phase IIa part of the study who received at least one dose of the study drugs at the MTD/RP2D and have measurable disease at screening.
- Disease Control Rate [ Time Frame: 2 Years ]Response will be assessed among participants eligible for the phase IIa part of the study who received at least one dose of the study drugs at the MTD/RP2D and have measurable disease at screening.
- Duration of Response [ Time Frame: 2 Years ]Response will be assessed among participants eligible for the phase IIa part of the study who received at least one dose of the study drugs at the MTD/RP2D and have measurable disease at screening.
- Progression Free Survival [ Time Frame: 2 Years ]PFS will be described using the method of Kaplan-Meier, and it will be presented with a 95% confidence interval. Participants alive without disease progression are censored at the date of last disease 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): NCT02871791
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sara Tolaney, MD||Dana-Farber Cancer Institute|