Clinical trial NCT05963984: A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Locally Advanced Breast Cancer
Breast Cancer
Keywords: Metastatic Breast Cancer
Advanced Breast Cancer
Breast Cancer
HR Positive
HER2-Negative
Lead sponsor: Carrick Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Benefit Response (CBR)
timeFrame: From randomization until Week 24
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 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)
measure: Duration of Response (DOR)
timeFrame: 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)
measure: Progression Free Survival (PFS)
timeFrame: 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)
measure: Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
timeFrame: From first dose of any study intervention through 28 days after the last dose of any study intervention
measure: Samuraciclib plasma exposure: Cmax
timeFrame: Day 1 of Cycles 2 and 3 (each cycle is 28 days)
measure: Samuraciclib plasma exposure: Ctrough
timeFrame: 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)
measure: Fulvestrant plasma exposure: Ctrough
timeFrame: 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)
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Ocala Oncology Center PL DBA Florida Cancer Affiliates
state: Florida
city: Baltimore
country: United States
facility: Mfsmc-Hjwci
state: Maryland
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health
state: Pennsylvania
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz
state: Komárom-esztergom
city: Salgótarján
country: Hungary
facility: Nograd Varmegyei Szent Lazar Korhaz
state: Nógrád
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Ciudad de México
country: Mexico
facility: Soltmed SMO
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer
state: Jalisco
city: Guadalajara
country: Mexico
facility: Renati Innovation S.A.P.I de C.V
state: Jalisco
city: Cuauhtémoc
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria Comunidad De
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Madrid, Comunidad De
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Málaga
country: Spain
facility: Hospital Vithas Málaga
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Ankara
country: Turkey
facility: Gulhane Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Gazi University
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
city: İzmir
country: Turkey
facility: I.E.U. Medical Point Hastanesi
Study officials:
References: