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

NCT05963984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Samuraciclib

Samuraciclib tablet by mouth once a day

DRUG

Fulvestrant

Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Carrick Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2025-03-20
Completion
2025-08-28
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Mexico
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05963984 on ClinicalTrials.gov