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A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

NCT05963997 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-03-23

No results posted yet for this study

Summary

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant 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 capsules by mouth once a day

DRUG

Elacestrant Dihydrochloride

Elacestrant tablets by mouth once a day

Sponsors & Collaborators

  • Berlin-Chemie AG Menarini Group

    collaborator INDUSTRY

  • Carrick Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2026-03-06
Completion
2026-03-06
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05963997 on ClinicalTrials.gov