Sacituzumab Tirumotecan for Breast Cancer

Recruiting at 10 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Metastatic cancer, Prior treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

2400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for people with high-risk, early-stage breast cancer that's triple-negative or has low hormone receptor levels and no HER2 protein. Participants must have a certain type of tumor size and lymph node involvement, be relatively healthy (ECOG status 0 or 1), have good organ function, and provide a biopsy from the breast tumor.

Inclusion Criteria

My cancer is large but hasn't spread beyond nearby lymph nodes.

My breast cancer is at an advanced local stage but hasn't spread widely.

My breast cancer is in an early stage but has spread to nearby lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan, pembrolizumab, and chemotherapy for 12 weeks, followed by surgery and optional radiation therapy

12 weeks

Bi-weekly and tri-weekly visits for drug administration

Surgery and Optional Radiation

Participants undergo surgery and may receive optional radiation therapy

3-6 weeks

Adjuvant Therapy

Participants receive pembrolizumab and additional adjuvant treatment based on physician's choice for up to 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 92 months

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Tirumotecan

Trial Overview The study tests if sacituzumab tirumotecan (sac-TMT) combined with pembrolizumab and chemotherapy improves outcomes in surgery and extends the time without cancer growth compared to just pembrolizumab with chemotherapy. Sac-TMT is targeted therapy aimed at controlling specific cancer cell growth.

How Is the Trial Designed?

Group I: sac-TMT Experimental Treatment 10 Interventions

Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.

Group II: Chemotherapy Active Control 9 Interventions

Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University