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)

Conditions

• Breast Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab tirumotecan — DRUG
  IV infusion
• Pembrolizumab — BIOLOGICAL
  IV infusion
• Paclitaxel — DRUG
  IV infusion
• Nab-paclitaxel — DRUG
  IV infusion
• Capecitabine — DRUG
  oral tablet
• Liposomal doxorubicin — DRUG
  IV infusion

Study Details

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.

Key Dates

Start date

Apr 14, 2024

Status verified

Jun 2026

Primary completion

Jul 11, 2027

Completion

Apr 12, 2031

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Sacituzumab tirumotecan
  Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
• Experimental: Arm B:Pembrolizumab + Sacituzumab tirumotecan
  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).
• Active Comparator: Arm C: Treatment of Physician's Choice (TPC)
  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.

Primary Outcome Measure

Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) [ Time Frame: Up to ~38 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (46)

Find similar trials in Chandler, AZ

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