Phase 2
Completed N=25
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
Source: ClinicalTrials.gov NCT02732119 ↗Enrolled (actual)
25
Serious AEs
26.0%
Results posted
May 2021
Primary outcomePrimary: Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I — 1; 1; 0; 0 Participants
Summary
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I |
1; 1; 0; 0; 1; 0 | — |
| PRIMARY Clinical Benefit Rate as Per Central Review by Group- Phase II |
6.5; 9.4; 65.2; 59.4; 65.2; 59.4 | — |
| PRIMARY Best Overall Responses (BOR) Summary Table as Per Central Review by Group - Phase II |
35; 21; 11; 11; 0; 0 | — |
| SECONDARY Everolimus Pharmacokinetic Plasma Concentrations by Cohort - Phase I |
7.82; 8.31; 8.28; 15.2; 17; 36.2 | — |
| SECONDARY Best Overall Responses (BOR) Summary Table as Per Central Review by Cohort - Phase I |
5; 7; 4; 3; 3; 3 | — |
| SECONDARY Clinical Benefit Rate as Per Central Review by Dose Cohort - Phase I |
10.0; 28.6; 62.5; 80.0; 100.0; 0 | — |
| SECONDARY Summary of Progression-free Survival (PFS) (Months), as Per Central Review by Group - Phase II |
8.0; 4.7 | — |
| SECONDARY Overall Survival (OS) by Group - Phase II |
27.4; NA | — |
| SECONDARY Duration of Overall Response (DOR) by Group - Phase II |
14.6; 6.4 | — |
| SECONDARY Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score by Group - Phase II |
NA; 12.0 | — |
| SECONDARY Everolimus Pharmacokinetic Plasma Concentrations - Phase II |
214; 132; 644; 372; 583; 323 | — |
Eligibility Criteria
Inclusion Criteria
- Adult men and women
- Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
- Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
- ECOG Performance Status 0 - 1
- Disease refractory to either, AI, tamoxifen or fulvestrant
- Previously treated on any CDK 4/6 inhibitor.
- Patient has adequate bone marrow and organ function.
Exclusion Criteria
- Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
- Patient has received more than one line of chemotherapy for advanced disease.
- Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
- Progressed on more than one CDK 4/6 inhibitor
- Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.
- Clinically significant, uncontrolled heart disease and/or recent cardiac events.
Data sourced from ClinicalTrials.gov (NCT02732119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.