Trial Title:
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
NCT ID:
NCT05963984
Condition:
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Conditions: Keywords:
Metastatic Breast Cancer
Advanced Breast Cancer
Breast Cancer
HR Positive
HER2-Negative
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Samuraciclib
Description:
Samuraciclib tablet by mouth once a day
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day
15
Arm group label:
Arm A
Arm group label:
Arm B
Arm group label:
Arm C
Other name:
Faslodex
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Address:
City:
Ocala
Zip:
34474
Country:
United States
Facility:
Name:
Mfsmc-Hjwci
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Facility:
Name:
Saint Luke's Cancer Institute
Address:
City:
Kansas City
Zip:
64111
Country:
United States
Facility:
Name:
Sidney Kimmel Cancer Center - Jefferson Health
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Facility:
Name:
The Center for Cancer and Blood Disorders
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Facility:
Name:
Szent Borbala Korhaz
Address:
City:
Tatabánya
Zip:
2800
Country:
Hungary
Facility:
Name:
Nograd Varmegyei Szent Lazar Korhaz
Address:
City:
Salgótarján
Zip:
3100
Country:
Hungary
Facility:
Name:
Semmelweis Egyetem
Address:
City:
Budapest
Zip:
1082
Country:
Hungary
Facility:
Name:
Soltmed SMO
Address:
City:
Ciudad de México
Zip:
03650
Country:
Mexico
Facility:
Name:
Actualidad Basada en la Investigación del Cáncer
Address:
City:
Guadalajara
Zip:
44280
Country:
Mexico
Facility:
Name:
Renati Innovation S.A.P.I de C.V
Address:
City:
Guadalajara
Zip:
44680
Country:
Mexico
Facility:
Name:
Cryptex Investigación Clínica S.A. de C.V.
Address:
City:
Cuauhtémoc
Zip:
06100
Country:
Mexico
Facility:
Name:
Oaxaca Site Management Organization S.C.
Address:
City:
Oaxaca
Zip:
68000
Country:
Mexico
Facility:
Name:
Centro de Investigacion Clinica de Oaxaca
Address:
City:
Oaxaca
Zip:
68020
Country:
Mexico
Facility:
Name:
Institut Català d'Oncologia - L'Hospitalet
Address:
City:
Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Santander
Zip:
39002
Country:
Spain
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Infanta Cristina
Address:
City:
Badajoz
Zip:
06080
Country:
Spain
Facility:
Name:
Parc de Salut Mar - Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Madrid
Zip:
28015
Country:
Spain
Facility:
Name:
Hospital Vithas Málaga
Address:
City:
Málaga
Zip:
29016
Country:
Spain
Facility:
Name:
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Facility:
Name:
Hospital Clinico de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
Gulhane Egitim ve Arastirma Hastanesi
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Facility:
Name:
Gazi University
Address:
City:
Ankara
Zip:
06120
Country:
Turkey
Facility:
Name:
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Facility:
Name:
Hacettepe Universite Hastaneleri
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Facility:
Name:
Trakya University
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Facility:
Name:
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
Address:
City:
Istanbul
Zip:
34093
Country:
Turkey
Facility:
Name:
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Facility:
Name:
I.E.U. Medical Point Hastanesi
Address:
City:
İzmir
Zip:
35575
Country:
Turkey
Start date:
December 14, 2023
Completion date:
June 16, 2025
Lead sponsor:
Agency:
Carrick Therapeutics Limited
Agency class:
Industry
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
Carrick Therapeutics Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963984
