Study on Sacituzumab Tirumotecan Alone and with Pembrolizumab Compared to Doctor's Choice Treatment for Advanced HR+/HER2- Breast Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06312176

Provider View

This clinical trial is comparing the effectiveness of sacituzumab tirumotecan, both alone and with pembrolizumab, against treatments chosen by doctors for patients with advanced hormone receptor positive, HER2-negative breast cancer that cannot be surgically removed.

Patient Parameters

Program Overview

The aim of this study is to see if sacituzumab tirumotecan, used alone or with pembrolizumab, is better than the treatments chosen by doctors for patients with advanced breast cancer that is hormone receptor positive and HER2-negative. The study will measure how long patients live without their cancer getting worse.

Eligibility Criteria

Inclusion Criteria

  • Have advanced breast cancer that cannot be removed by surgery and is hormone receptor positive and HER2-negative.
  • Cancer has worsened after one or more hormone therapies, including one with a CDK4/6 inhibitor.
  • Eligible to receive chemotherapy.
  • Have a good general health status, with a performance score of 0 or 1.
  • Have adequate organ function.
  • If HIV-positive, must have well-controlled HIV with medication.
  • If Hepatitis B positive, must have been on antiviral therapy for at least 4 weeks with undetectable viral load.
  • If previously infected with Hepatitis C, must have an undetectable viral load.

Exclusion Criteria

  • Have breast cancer that can be treated with the aim of curing it.
  • Cancer returned less than 6 months after finishing chemotherapy, making you eligible for second-line treatment.
  • Have advanced cancer that is spreading quickly and could cause life-threatening issues.
  • Have had chemotherapy for advanced breast cancer before.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of lung disease requiring steroids or currently have lung disease.
  • Have an active infection needing treatment.

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