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RecruitingPhase 3

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic 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 sacituzumab tirumotecan alone or with pembrolizumab against treatment chosen by a doctor. It is for people with HR+/HER2- breast cancer that has spread nearby and cannot be removed by surgery, or has spread to other parts of the body. The study checks which treatment keeps cancer from getting worse for longer.

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

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

Eligibility

Who can join

  • Has confirmed HR+/HER2- breast cancer that cannot be removed by surgery or has spread elsewhere. This cancer uses hormones to grow and is negative for a protein called HER2.
  • Scans show cancer got worse after at least one hormone treatment for advanced cancer. At least one treatment included a CDK4/6 inhibitor, a drug that blocks cancer cell growth.
  • Can receive chemotherapy.
  • Is fully active or can do light work despite limits on hard physical activity, checked within 7 days before treatment group assignment.
  • Has organs that work well enough.
  • If living with HIV, it must be well controlled with HIV medicines.
  • If testing positive for hepatitis B surface antigen, has taken hepatitis B medicine for at least 4 weeks and has no virus detected in the blood.
  • If there is a history of hepatitis C, has no hepatitis C virus detected in the blood.

Who can't join

  • Has breast cancer that can be treated with the goal of a cure.
  • Cancer returned less than 6 months after finishing chemotherapy given before or after surgery, making the person eligible for second-line treatment.
  • Has cancer spread to internal organs that causes symptoms and could quickly become life-threatening.
  • Has already received chemotherapy for breast cancer that cannot be removed by surgery or has spread elsewhere.
  • Has an active autoimmune disease, where the immune system attacks the body, that needed treatment affecting the whole body in the past 2 years.
  • Has current lung inflammation or scarring, or a history of these problems not caused by infection that required steroids.
  • Has an active infection that needs treatment affecting the whole body.

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

Official eligibility criteria

Inclusion Criteria: * Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer * Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor * Is a chemotherapy candidate * Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization * Has adequate organ function * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable Exclusion Criteria: * Has breast cancer amenable to treatment with curative intent * Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment * Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications * Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer * Active autoimmune disease that has required systemic treatment in the past 2 years * History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy

Study sites (46)

AZ

CA

CO

CT

FL

GA

IL

KY

LA

MA

MD

MI

MO

NC

NY

OH

OR

PA

TX

VA

WI