Clinical trial · Interventional
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
- interventionNames
- Drug: Ribociclib
- Drug: Everolimus
- Drug: Exemestane
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
- interventionNames
- Drug: Ribociclib
- Drug: Everolimus
- Drug: Exemestane
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available