RightFit
RecruitingPhase 3

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

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests adding sacituzumab tirumotecan (sac-TMT), a targeted cancer drug, to pembrolizumab and chemotherapy. It is for people with untreated, early-stage breast cancer that has a high risk of getting worse or coming back and is triple-negative or HR-low positive/HER2-negative. Researchers want to see if adding sac-TMT leaves less cancer at surgery and helps people live longer without cancer growing, spreading, or coming back.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have untreated breast cancer that has not spread to distant parts of the body and meets the study’s tumor size and nearby lymph node rules.
  • Have triple-negative breast cancer or HR-low positive/HER2-negative breast cancer, confirmed by the study lab. These types have no or low levels of certain hormone-related proteins and HER2.
  • Provide a sample from the main breast tumor, taken with a hollow needle, for the study lab.
  • Be fully active or able to do light work, as checked within 28 days before treatment starts.
  • Have organs that work well enough for study treatment.

Who can't join

  • Have breast cancer that has spread to distant body parts, or have nearby lymph node spread rated cN3.
  • Have had treatment for this breast cancer, including radiation, drug treatment, or surgery; or have had surgery to remove the main tumor for testing or remove underarm lymph nodes.
  • Have received cancer drugs, including study drugs, within 4 weeks before study treatment starts.
  • Have received certain drugs that act on immune cells, including drugs targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137.
  • Have received an antibody-drug conjugate, a drug that carries cancer medicine to cells, targeting TROP2 or containing a topoisomerase I blocker.
  • Have received a live or weakened-live vaccine within 30 days before the first study dose.
  • Have another cancer that is getting worse or needed treatment in the past 5 years, or an uncontrolled illness affecting the body.
  • Have current or suspected lung inflammation or lung tissue disease, or had lung inflammation not caused by infection that needed steroid treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment: * cT1c, N1-N2 * cT2, N0-N2 * cT3, N0-N2 * cT4a-d, N0-N2 * The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1). * Demonstrates adequate organ function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement * Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer * Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1. * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137). * Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC). * Received prior treatment with a topoisomerase I inhibitor-containing ADC. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Uncontrolled systemic disease. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Study sites (64)

AZ

CA

CO

FL

GA

IL

IN

LA

MA

MD

ME

MO

ND

NE

NJ

NV

OH

OR

SC

SD

TN

TX

UT

VA

WA

WI