What is sacituzumab tirumotecan studying for triple-negative breast cancer?

Sacituzumab tirumotecan is being studied in combination with pembrolizumab to see if it improves invasive disease-free survival in adults with triple-negative breast cancer who did not fully respond to initial therapy. The trial compares this combination to treatments selected by physicians. The study is sponsored by Merck Sharp & Dohme LLC and aims to find better options for patients after surgery.

Who may be eligible for this triple-negative breast cancer clinical trial?

Adults aged 18 and older with centrally confirmed triple-negative breast cancer who have had neoadjuvant therapy and surgery but did not achieve a complete response may be eligible. Participants must be able to receive pembrolizumab and meet other health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this triple-negative breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06393374

Phase 3 Study Comparing Sacituzumab Tirumotecan Plus Pembrolizumab to Doctors Choice Treatment in Adults With Triple-Negative Breast Cancer Who Did Not Achieve Complete Response After Neoadjuvant Therapy

Led by Merck Sharp & Dohme LLC · Updated on 2026-08-07

1530

Participants Needed

308

Research Sites

365 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the benefits and safety of adding sacituzumab tirumotecan to pembrolizumab compared to treatment chosen by a physician in adults with triple-negative breast cancer TNBC who have already received pre-surgery therapy but did not achieve a complete response at surgery. This Phase 3, randomized, open-label trial aims to see if the combination treatment improves invasive disease-free survival compared to current standard options. The study is sponsored by Merck Sharp & Dohme LLC and focuses on patients who need additional therapy after surgery. Participants in one group receive sacituzumab tirumotecan by intravenous infusion every two weeks combined with pembrolizumab every six weeks for a total of 24 weeks. They also receive pre-medication such as antihistamines, H2 antagonists, acetaminophen, and dexamethasone before sacituzumab tirumotecan infusions. The comparison group receives pembrolizumab every six weeks alone or with oral capecitabine twice daily on specific schedules for 24 weeks. The study uses random assignment to these treatment groups and follows participants for long periods. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess invasive disease-free survival for up to about 77 months and track overall survival, recurrence, and quality of life measures for up to around 101 months. Safety will be monitored by recording adverse events and any treatment discontinuations due to side effects. The study includes detailed evaluations of physical functioning, fatigue, and role functioning using questionnaires. Participation lasts several years with ongoing assessments to evaluate long-term outcomes and safety.

CONDITIONS

Brief Title

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Centrally confirmed triple-negative breast cancer as defined by ASCO/CAP guidelines
No evidence of locoregional or distant relapse
Received neoadjuvant treatment based on the KEYNOTE-522 regimen followed by surgery per NCCN guidelines
All clinically evident disease in breast and/or lymph nodes surgically removed and recovered from surgery
Did not achieve pathological complete response at surgery
Able to continue adjuvant pembrolizumab
Randomization within 16 weeks of surgical resection
Completed and recovered from adjuvant radiation therapy if indicated
Provided surgical tissue for central TROP2 status determination
For capable sperm producers: agree to avoid sperm donation and use effective contraception or abstain
For females assigned at birth: not pregnant or breastfeeding and either not of childbearing potential or using effective contraception
Recovered from prior anticancer therapy adverse events to Grade 1 or baseline (except alopecia)
HIV-infected with well controlled HIV on ART
ECOG performance status 0 to 1 within 7 days before first treatment dose
HBsAg positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load prior to randomization

You will not qualify if you...

Known deleterious or suspected deleterious germline BRCA mutation eligible for olaparib
Grade greater than 2 peripheral neuropathy
Severe dry eye syndrome or corneal disease preventing healing
Active or previous inflammatory bowel disease requiring immunosuppressive medication
Uncontrolled significant cardiovascular or cerebrovascular disease within 6 months prior
Prior treatment with TROP2-directed or topoisomerase I inhibitor-containing ADC
Prior adjuvant anticancer therapy except radiation
Current use of strong CYP3A4 inducers/inhibitors that cannot be stopped
Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents except pembrolizumab as neoadjuvant
Prior systemic anticancer therapy within 4 weeks before randomization except neoadjuvant chemotherapy
Radiotherapy within 3 weeks before study intervention or corticosteroids for radiation toxicity
Live or live-attenuated vaccine within 30 days before first dose
Use of investigational agents or devices within 4 weeks before intervention
Known progressing additional malignancy or requiring active treatment within 5 years
Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent within 7 days before treatment
Active autoimmune disease requiring systemic treatment in past 2 years
History or current pneumonitis/interstitial lung disease requiring steroids
Active infection requiring systemic therapy
HIV with history of Kaposi's sarcoma or Multicentric Castleman's Disease
Concurrent active hepatitis B and C infection
History of allogeneic tissue or solid organ transplant

Research Team

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Phase 3 Study Comparing Sacituzumab Tirumotecan Plus Pembrolizumab to Doctors Choice Treatment in Adults With Triple-Negative Breast Cancer Who Did Not Achieve Complete Response After Neoadjuvant Therapy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria