Comparing sacituzumab tirumotecan and pembrolizumab to standard treatment for advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of sacituzumab tirumotecan, both as a standalone treatment and in combination with pembrolizumab, against the treatment of physician's choice for patients with hormone receptor positive and HER2 negative unresectable locally advanced or metastatic breast cancer. The primary goal is to determine if these treatments can improve progression-free survival compared to standard options. Participants will be monitored for disease progression using established criteria, ensuring a rigorous assessment of treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
* Is a chemotherapy candidate
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has adequate organ function
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

* Has breast cancer amenable to treatment with curative intent
* Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
* Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy

Where it's running

• Ironwood Cancer & Research Centers ( Site 0066)
  Chandler, Arizona, United States Recruiting
• Banner MD Anderson Cancer Center-Oncology ( Site 0004)
  Gilbert, Arizona, United States Recruiting
• Providence Medical Foundation-Oncology ( Site 0020)
  Fullerton, California, United States Recruiting
• University of Colorado Anschutz Medical Campus ( Site 0061)
  Aurora, Colorado, United States Recruiting
• UCHealth Cherry Creek Medical Center ( Site 0094)
  Denver, Colorado, United States Recruiting
• Stamford Hospital ( Site 0049)
  Stamford, Connecticut, United States Recruiting

+209 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab tirumotecan plus pembrolizumab as first-line maintenance for metastatic cervical cancer

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• Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab alone for pMMR endometrial cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.