Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

Conditions

• Breast Cancer
• Breast Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Patritumab deruxtecan — BIOLOGICAL
  Patritumab deruxtecan administered via IV infusion
• Trastuzumab — BIOLOGICAL
  Trastuzumab administered via IV infusion
• Trastuzumab Biosimilar — BIOLOGICAL
  Trastuzumab biosimilar administered via IV infusion
• Pertuzumab — BIOLOGICAL
  Pertuzumab administered via IV infusion
• Tucatinib — BIOLOGICAL
  Tucatinib administered as oral tablets

Study Details

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Key Dates

Start date

Feb 26, 2025

Status verified

May 2026

Primary completion

Apr 18, 2030

Completion

Apr 18, 2030

Study Design

Enrollment

81 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Patritumab deruxtecan plus trastuzumab
  Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
• Experimental: Patritumab deruxtecan plus pertuzumab and trastuzumab
  Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
• Experimental: Patritumab deruxtecan plus trastuzumab and tucatinib
  Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 21 days ]

Central Contacts

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

Locations (5)

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