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Monoclonal Antibodies

Sacituzumab Tirumotecan + Pembrolizumab for Breast Cancer

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer

Has adequate organ function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~77 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

"This trial is comparing a drug called sacituzumab tirumotecan alone and in combination with pembrolizumab to the standard treatment for patients with hormone receptor positive/human epider

Who is the study for?

This trial is for adults with HR+/HER2- advanced or metastatic breast cancer that's worsened after hormone therapy, including one with a CDK4/6 inhibitor. They should be able to undergo chemotherapy, have good physical function (ECOG 0-1), and controlled HIV if positive. Hepatitis B patients can join if treated for 4 weeks and virus undetectable; same for Hepatitis C with no detectable virus.

What is being tested?

The study tests Sacituzumab Tirumotecan alone and combined with Pembrolizumab against doctors' choice of treatment in participants. It aims to see which option better stops the cancer from progressing using standard criteria assessed by independent reviewers who don't know which treatment was given.

What are the potential side effects?

Possible side effects include reactions related to infusion, fatigue, nausea, low blood cell counts increasing infection risk or bleeding tendency, liver toxicity, hair loss from Paclitaxel or Nab-paclitaxel, skin reactions from Capecitabine and heart issues from Liposomal doxorubicin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer cannot be surgically removed, is HR+ and HER2-.

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My organs are functioning well.

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My HR+/HER2- breast cancer has worsened despite hormone therapy and a CDK4/6 inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~77 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~77 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~77 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)

Secondary study objectives

Change from baseline in diarrhea score, on the EORTC QLQ-C30

Change from baseline in emotional functioning score, on the EORTC QLQ-C30

Change from baseline in fatigue score, on the EORTC QLQ-C30

+13 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B:Pembrolizumab + Sacituzumab tirumotecanExperimental Treatment2 Interventions

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).

Group II: Arm A: Sacituzumab tirumotecanExperimental Treatment1 Intervention

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.

Group III: Arm C: Treatment of Physician's Choice (TPC)Active Control4 Interventions

At the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 3Eligibility criteria met