A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Conditions

• Triple Negative Breast Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab tirumotecan — BIOLOGICAL
  IV Infusion
• Pembrolizumab — BIOLOGICAL
  IV Infusion
• Rescue Medication — DRUG
  Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).
• Paclitaxel — DRUG
  IV Infusion
• Nab-paclitaxel — DRUG
  IV Infusion
• Gemcitabine — DRUG
  IV Infusion
• Carboplatin — DRUG
  IV Infusion

Study Details

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Key Dates

Start date

Mar 16, 2025

Status verified

May 2026

Primary completion

May 18, 2030

Completion

May 18, 2030

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Sacituzumab Tirumotecan
  Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation.
• Experimental: Arm B: Sacituzumab Tirumotecan + Pembrolizumab
  Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to \~2 years).
• Active Comparator: Arm C: Treatment of Physician's Choice (TPC)
  Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m\^2 once every week (Q1W) OR paclitaxel IV 90 mg/m\^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m\^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m\^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation.

Primary Outcome Measure

Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC) [ Time Frame: Up to ~39 months ]

Central Contacts

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

Locations (38)

Find similar trials in Mobile, AL

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