Sacituzumab tirumotecan plus pembrolizumab and chemotherapy for high-risk early triple-negative and HR-low/HER2-negative 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 phase 3 study gives sacituzumab tirumotecan together with pembrolizumab and standard chemotherapy to people with previously untreated, high‑risk early‑stage triple‑negative or HR‑low/HER2‑negative breast cancer in the neoadjuvant setting. Participants must provide a core needle biopsy at screening for central confirmation of tumor subtype and will be closely monitored for tumor response and treatment safety. The primary focus is on the amount of residual cancer found in the breast and regional lymph nodes at the time of surgery. The trial is sponsored by Merck and is being conducted at several cancer centers in Arizona.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:

  * cT1c, N1-N2
  * cT2, N0-N2
  * cT3, N0-N2
  * cT4a-d, N0-N2
* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
* Demonstrates adequate organ function.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
* Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I inhibitor-containing ADC.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Uncontrolled systemic disease.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Where it's running

• Banner MD Anderson Cancer Center ( Site 0066)
  Gilbert, Arizona, United States Recruiting
• Mayo Clinic Cancer Center ( Site 0034)
  Phoenix, Arizona, United States Recruiting
• University of Arizona Cancer Center ( Site 0035)
  Tucson, Arizona, United States Recruiting
• Roy and Patricia Disney Family Cancer Center ( Site 0055)
  Burbank, California, United States Recruiting
• Community Cancer Institute ( Site 0100)
  Clovis, California, United States Recruiting
• Providence Medical Foundation ( Site 0080)
  Fullerton, California, United States Recruiting

+285 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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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.