Treatment for triple-negative breast cancer using sacituzumab tirumotecan and pembrolizumab

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 investigates the effectiveness of sacituzumab tirumotecan, both alone and in combination with pembrolizumab, in treating patients with triple-negative breast cancer (TNBC). The primary objective is to determine whether this treatment regimen can improve overall survival and prevent cancer progression compared to standard chemotherapy. Participants will be monitored for their response to the treatment and any potential side effects. The study aims to provide insights into new therapeutic options for patients with advanced TNBC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
* Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
* Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
* Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

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

* Has breast cancer amenable to treatment with curative intent
* Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
* Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
* Has Grade ≥2 peripheral neuropathy
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has skin only metastatic disease
* Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
* History of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where it's running

• USA Mitchell Cancer Institute ( Site 0090)
  Mobile, Alabama, United States Recruiting
• Ironwood Cancer & Research Centers ( Site 0036)
  Chandler, Arizona, United States Recruiting
• City of Hope ( Site 0097)
  Duarte, California, United States Recruiting
• City of Hope Lennar Foundation Cancer Center ( Site 0099)
  Irvine, California, United States Recruiting
• UCLA Department of Medicine - Hematology & Oncology ( Site 0047)
  Los Angeles, California, United States Recruiting
• UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
  San Francisco, California, United States Recruiting

+235 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 in advanced biliary tract cancer

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  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

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• Sacituzumab tirumotecan with or without pembrolizumab in ovarian clear cell cancer that has come back or spread

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  Recruiting Phase 2 Tufts Medical Center · Boston, Massachusetts · NCT07718854

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

  This trial tests whether adding the antibody-drug conjugate sacituzumab tirumotecan to pembrolizumab (with or without bevacizumab) as maintenance treatment can help people with metastatic cervical cancer live longer or keep the cancer from growing.

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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.