Study on Samuraciclib and Fulvestrant for Advanced Breast Cancer in Adults

Sponsor: Carrick Therapeutics Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05963984

Provider View

This clinical trial is testing whether the combination of two drugs, Samuraciclib and Fulvestrant, is more effective than Fulvestrant alone in treating adults with advanced breast cancer that is hormone receptor positive and HER2-negative.

Patient Parameters

Program Overview

The aim of this study is to determine if using Samuraciclib together with Fulvestrant can provide better treatment outcomes compared to using Fulvestrant by itself in adults with advanced breast cancer that is hormone receptor positive and HER2-negative. Researchers will evaluate the safety and effectiveness of this combination therapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer.
  • Cancer must have worsened during or within 6 months after the last treatment.
  • Previously treated with a combination of an aromatase inhibitor (AI) and a CDK4/6 inhibitor.
  • Known status of TP53 gene mutation.
  • Must have measurable cancer or cancer in the bones only, as defined by specific medical criteria.
  • Pre/peri-menopausal women must have started treatment with a hormone therapy at least 4 weeks before the study.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live for more than 12 weeks according to the treating doctor.

Exclusion Criteria

  • Have inflammatory breast cancer.
  • Have any other active cancer within the last 3 years, except for certain skin cancers or cervical cancer that has been treated.
  • Have had more than one line of hormone therapy for advanced cancer.
  • Have poor liver, kidney, or bone marrow function.
  • Have significant heart disease.
  • Have current or past cancer spread to the brain or spinal cord.
  • Be pregnant or breastfeeding.

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