A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

Breast Cancer Clinical Trial

— SUMIT-BC  

Official title:

An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963984
• Other study ID #: CT7001_002
• Secondary ID: 2023-503903-27-0
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2023
• Est. completion date: June 16, 2025

Study information

• Verified date: June 2024
• Source: Carrick Therapeutics Limited
• Contact: Clinical Operations
• Phone: +353 1 5996873
• Email: hello[@]carricktherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 16, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Intervention

Drug:
• Samuraciclib
Samuraciclib tablet by mouth once a day
• Fulvestrant
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15

Locations

Country	Name	City	State
Hungary	Semmelweis Egyetem	Budapest
Hungary	Nograd Varmegyei Szent Lazar Korhaz	Salgótarján	Nógrád
Hungary	Szent Borbala Korhaz	Tatabánya	Komárom-esztergom
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Parc de Salut Mar - Hospital del Mar	Barcelona
Spain	Institut Català d'Oncologia - L'Hospitalet	Hospitalet de Llobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid	Madrid, Comunidad De
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Vithas Málaga	Málaga
Spain	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria Comunidad De
Spain	Hospital Clinico de Valencia	Valencia
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Gazi University	Ankara
Turkey	Gulhane Egitim ve Arastirma Hastanesi	Ankara
Turkey	Hacettepe Universite Hastaneleri	Ankara
Turkey	Trakya University	Edirne
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	I.E.U. Medical Point Hastanesi	Izmir
United States	Mfsmc-Hjwci	Baltimore	Maryland
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Saint Luke's Cancer Institute	Kansas City	Missouri
United States	Ocala Oncology Center PL DBA Florida Cancer Affiliates	Ocala	Florida
United States	Sidney Kimmel Cancer Center - Jefferson Health	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Carrick Therapeutics Limited	Pfizer

Countries where clinical trial is conducted

United States,  Hungary,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Response (CBR)	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.	From randomization until Week 24
Secondary	Objective Response Rate (ORR)	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.	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)
Secondary	Duration of Response (DOR)	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.	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)
Secondary	Progression Free Survival (PFS)	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.	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)
Secondary	Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0	Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.	From first dose of any study intervention through 28 days after the last dose of any study intervention
Secondary	Samuraciclib plasma exposure: Cmax		Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Secondary	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)
Secondary	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)