Sacituzumab Tirumotecan for Breast Cancer

Recruiting at 134 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?

This trial tests a new treatment for certain types of early-stage breast cancer with a higher risk of recurrence or progression. It targets triple-negative breast cancer and hormone receptor-low positive/HER2-negative breast cancer, which have low or no levels of specific growth-related proteins. Researchers aim to determine if adding sacituzumab tirumotecan, an experimental drug, to standard treatments like pembrolizumab and chemotherapy more effectively reduces cancer in tumors and lymph nodes. Individuals who have not yet received treatment for their high-risk, early-stage breast cancer and meet these specific cancer type criteria may be suitable candidates for the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have received any prior treatment for the currently diagnosed breast cancer or certain other therapies recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sacituzumab tirumotecan (often called sac-TMT) is generally safe for people. Studies have found that its side effects are usually mild or manageable. For example, in patients with advanced cancer, sac-TMT was tolerable and helped slow cancer growth.

Sac-TMT has been tested in other types of breast cancer and has delayed cancer growth or spread. This indicates that the treatment is both effective and relatively safe compared to traditional chemotherapy. While monitoring for side effects is important, evidence so far supports the safety of sac-TMT in treating breast cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike standard breast cancer treatments that often rely on traditional chemotherapy or hormone therapies, sacituzumab tirumotecan introduces a new approach by combining a targeted antibody-drug conjugate (ADC) with immunotherapy. This treatment uses sacituzumab, which specifically targets cancer cells, delivering the chemotherapy directly to them and potentially enhancing effectiveness while minimizing damage to healthy cells. Furthermore, the addition of pembrolizumab, an immune checkpoint inhibitor, aims to boost the body's immune response against cancer. Researchers are excited about this innovative combination because it represents a dual approach, targeting both the cancer cells directly and enhancing the body's natural defense mechanisms.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that sacituzumab tirumotecan (sac-TMT), one of the treatments under study in this trial, yields promising results for breast cancer. One study found that sac-TMT extended the time patients lived without their cancer worsening, compared to standard chemotherapy, in cases of hormone receptor-positive and HER2-negative breast cancer. Another study reported that 70.7% of patients experienced a reduction in cancer size with sac-TMT. Additionally, the treatment controlled cancer growth in 92.7% of patients. Overall, sac-TMT offers significant benefits, particularly for those with difficult-to-treat breast cancer. ^{1 2 3 6 7}

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

Citations

1. onclive.com onclive.com/view/sac-tmt-yields-pfs-benefit-over-chemotherapy-in-pretreated-hr-her2-metastatic-breast-cancer

Sac-TMT Yields PFS Benefit Over Chemotherapy in ... Sacituzumab tirumotecan significantly improved progression-free survival compared to chemotherapy in HR+/HER2– breast cancer, reducing disease ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1019

Initial results from the phase II OptiTROP-Breast05 study. The objective response rate (ORR) was 70.7% (29/41, 3 unconfirmed PR) and the disease control rate (DCR) was 92.7%. Median duration of response ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40217078/

Sacituzumab tirumotecan in previously treated metastatic ... Sac-TMT demonstrated statistically significant and clinically meaningful improvements in PFS compared to chemotherapy, with a manageable safety ...

4. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01705-2

Results of a phase 1/2 study of sacituzumab tirumotecan in ... Our study also demonstrated an ORR of 32%, median PFS of 8 months, and median OS of 14 months with sac-TMT in patients with previously treated ...

5. cancertherapyadvisor.com cancertherapyadvisor.com/reports/sacituzumab-tirumotecan-tnbc/

Sacituzumab Tirumotecan Shows Promise in Advanced ... The median progression-free survival (PFS) was 13.4 months for all patients and 13.1 months for the patients with a PD-L1 CPS of less than 10.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06966700

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, ... High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment.

7. targetedonc.com targetedonc.com/view/sac-tmt-improves-pfs-in-hr-her2-metastatic-breast-cancer

Sac-TMT Improves PFS in HR+/HER2– Metastatic Breast ... Sacituzumab tirumotecan significantly improves progression-free survival in HR+/HER2– breast cancer compared with traditional chemotherapy.