Sacituzumab Tirumotecan for Early-Stage Breast Cancer

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Recruiting Phase 3 Interventional Study
Breast Neoplasms Triple Negative Breast Neoplasms HR Low-Positive/HER2-Negative Breast Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,400 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with early-stage high-risk breast cancer who have not received any treatment yet. Participants will receive a new medicine along with standard chemotherapy to see if it helps reduce cancer cells more effectively.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have early-stage, high-risk breast cancer that hasn't been treated before.
  • I have triple-negative breast cancer or HR-low positive/HER2 negative breast cancer.
  • I can provide a biopsy from my breast tumor.
  • I have an ECOG performance status of 0 or 1.
  • I have adequate organ function.

You may not be able to join if

  • I have metastatic breast cancer.
  • I have had any previous treatments for my breast cancer.
  • I have undergone surgery on my primary tumor or lymph nodes before joining this study.
  • I have received any anticancer therapy within 4 weeks before starting the trial.
  • I have received prior medication targeting immune checkpoints.
  • I have received a TROP2-targeted antibody-drug conjugate.
  • I have received a vaccine within 30 days before the study treatment.
  • I have a history of serious lung issues that required steroids.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About 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 …
Trial Locations
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Eligibility Criteria
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 editi…
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