Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor. (TRINITI-1)
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|ClinicalTrials.gov Identifier: NCT02732119|
Recruitment Status : Active, not recruiting
First Posted : April 8, 2016
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Ribociclib Drug: Everolimus Drug: Exemestane||Phase 1 Phase 2|
The purpose of the phase I dose escalation part of this study is to estimate the MTD(s) and/or identify the RP2D of the combination treatment of ribociclib+ everolimus + exemestane when dosed continuously in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.
The purpose of the phase II portion of this trial will be to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib triplet following progression on a CDK 4/6 inhibitor. This part of the study will be conducted using a Simon's optimal two-stage design.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor|
|Actual Study Start Date :||June 14, 2016|
|Actual Primary Completion Date :||October 17, 2018|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: ribociclib + everolimus + exemestane
ribociclib with everolimus and exemestane daily
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
supplied in 25 mg tablets taken orally, daily for 28 day cycle
- Phase I: Maximum Tolerated Dose (MTD) and/or the Recommended Phase II Dose (RP2D) for the triplet combination [ Time Frame: up to 6 months ]
- Phase II: Clinical Benefit Rate (CBR) among subjects receiving triplet therapy [ Time Frame: 24 weeks ]
- Phase II: Centrally assessed progression Free Survival (PFS) [ Time Frame: up to approximately 12 months ]
- Phase II: Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]This is defined as the time from treatment initiation with study treatment until death as a result of any cause.
- Phase II: Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]Overall response rate (ORR) defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1
- Phase II: Duration of Overall Response (DOR) [ Time Frame: Up to approximately 12 months ]Duration of Overall Response defined as the time between the initial response to the treatment with the combination of ribociclib+everolimus+ exemestane, and subsequent disese progression or recurrence.
- Phase II: Time to definitive deterioration of ECOG performance status in one category of the score [ Time Frame: Up to approximately 12 months ]Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.
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): NCT02732119
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