Status:
ACTIVE_NOT_RECRUITING
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
Lead Sponsor:
Carrick Therapeutics Limited
Collaborating Sponsors:
Berlin-Chemie AG Menarini Group
Conditions:
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advan...
Detailed Description
This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
- Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
- Received prior AI in combination with a CDK4/6i as the last therapy
- Known TP53 and ESR1 mutation status.
- Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
- Expected life expectancy of \>12 weeks in the judgement of the treating investigator.
Exclusion
- Inflammatory breast cancer.
- Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
- Inadequate hepatic, renal, and bone marrow function.
- Clinically significant cardiovascular disease.
- Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05963997
Start Date
October 9 2023
End Date
December 23 2025
Last Update
May 11 2025
Active Locations (23)
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1
Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
Chicago, Illinois, United States, 60611
2
Site 42 - Dana-Farber Cancer Institute, EDDC
Boston, Massachusetts, United States, 02215
3
Site 35 - Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States, 44106
4
Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology
San Antonio, Texas, United States, 78229