Status:
COMPLETED
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
Lead Sponsor:
Carrick Therapeutics Limited
Collaborating Sponsors:
Pfizer
Conditions:
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Horm...
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 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 :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05963984
Start Date
November 16 2023
End Date
August 28 2025
Last Update
December 26 2025
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, United States, 34474
2
Mfsmc-Hjwci
Baltimore, Maryland, United States, 21237
3
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
4
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States, 19107