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

Summary

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

Conditions

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• HR Low-Positive/HER2-Negative Breast Neoplasms

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Rescue Medication

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Doxorubicin

IV infusion

DRUG

Epirubicin

IV infusion

DRUG

Cyclophosphamide

IV infusion

DRUG

Capecitabine

Oral tablet

DRUG

Olaparib

Oral tablet

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2033-03-23

Completion

2034-12-29

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Canada
• Chile
• China
• Colombia
• Czechia
• Finland
• France
• Germany
• Greece
• Guatemala
• Hong Kong
• Hungary
• Israel
• Italy
• Japan
• Malaysia
• New Zealand
• Norway
• Peru
• Philippines
• Poland
• Portugal
• Romania
• Singapore
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• Ukraine
• United Kingdom
• Vietnam

Study Locations