A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
- Conditions
- Metastatic Breast CancerLocally Advanced Breast CancerBreast Cancer
- Interventions
- Registration Number
- NCT05963984
- Lead Sponsor
- Carrick Therapeutics Limited
- 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 Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Samuraciclib Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. Arm A Fulvestrant Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. Arm B Samuraciclib Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. Arm B Fulvestrant Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. Arm C Fulvestrant Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.
- Primary Outcome Measures
Name Time Method Clinical Benefit Response (CBR) From randomization until Week 24 CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 From first dose of any study intervention through 28 days after the last dose of any study intervention Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Samuraciclib plasma exposure: Ctrough Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5, and 6; and within 28 days of last dose (each cycle is 28 days) Duration of Response (DOR) Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.
Fulvestrant plasma exposure: Ctrough Cycle 1 Days 8 and 15; Day 1 of Cycles 2, 3, 4, 5 and 6; and within 28 days of last dose (each cycle is 28 days) Objective Response Rate (ORR) Time from the date of first dose of study intervention until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause.
Samuraciclib plasma exposure: Cmax Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Trial Locations
- Locations (32)
Ocala Oncology Center PL DBA Florida Cancer Affiliates
🇺🇸Ocala, Florida, United States
Mfsmc-Hjwci
🇺🇸Baltimore, Maryland, United States
Saint Luke's Cancer Institute
🇺🇸Kansas City, Missouri, United States
Sidney Kimmel Cancer Center - Jefferson Health
🇺🇸Philadelphia, Pennsylvania, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Szent Borbala Korhaz
🇭🇺Tatabánya, Komárom-esztergom, Hungary
Nograd Varmegyei Szent Lazar Korhaz
🇭🇺Salgótarján, Nógrád, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Soltmed SMO
🇲🇽Ciudad de México, Distrito Federal, Mexico
Actualidad Basada en la Investigación del Cáncer
🇲🇽Guadalajara, Jalisco, Mexico
Renati Innovation S.A.P.I de C.V
🇲🇽Guadalajara, Jalisco, Mexico
Cryptex Investigación Clínica S.A. de C.V.
🇲🇽Cuauhtémoc, Mexico
Oaxaca Site Management Organization S.C.
🇲🇽Oaxaca, Mexico
Centro de Investigacion Clinica de Oaxaca
🇲🇽Oaxaca, Mexico
Institut Català d'Oncologia - L'Hospitalet
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria Comunidad De, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Parc de Salut Mar - Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
MD Anderson Cancer Center
🇪🇸Madrid, Spain
Hospital Vithas Málaga
🇪🇸Málaga, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Spain
Gulhane Egitim ve Arastirma Hastanesi
🇹🇷Ankara, Turkey
Gazi University
🇹🇷Ankara, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
🇹🇷Ankara, Turkey
Hacettepe Universite Hastaneleri
🇹🇷Ankara, Turkey
Trakya University
🇹🇷Edirne, Turkey
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
🇹🇷Istanbul, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
🇹🇷Istanbul, Turkey
I.E.U. Medical Point Hastanesi
🇹🇷İzmir, Turkey