A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Conditions

• Breast Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Patritumab deruxtecan — BIOLOGICAL
  Administered via intravenous (IV) infusion
• Paclitaxel — DRUG
  Administered via IV infusion
• Nab-paclitaxel — DRUG
  Administered via IV infusion
• Capecitabine — DRUG
  Administered via oral tablets
• Liposomal doxorubicin — DRUG
  Administered via IV infusion
• Trastuzumab deruxtecan — BIOLOGICAL
  Administered via IV infusion

Study Details

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Key Dates

Start date

Jul 21, 2025

Status verified

Jun 2026

Primary completion

Jul 14, 2033

Completion

Jul 14, 2033

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Patritumab Deruxtecan
  Participants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.
• Active Comparator: Treatment of Physician's Choice
  Participants receive treatment of physician's choice (TPC) for up to 13 months. The TPC may be any of the following options: Paclitaxel (80 mg/m\^2) on Days 1, 8, 15, and 22 of each 4-week cycle; Paclitaxel (90 mg/m\^2) on Days 1, 8, and 15 of each 4-week cycle; Nab-paclitaxel (100 mg/m\^2) on Days 1, 8, and 15 of each 4-week cycle; Capecitabine (1000 mg/m\^2) bid on Days 1 to 14 of each 3-week cycle; Liposomal doxorubicin (50 mg/m\^2) on Day 1 of each 4-week cycle; or trastuzumab deruxtecan (T-DXd) (5.4 mg/kg) Q3W.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to approximately 45 months ]

Central Contacts

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

Locations (33)

Find similar trials in Daphne, AL

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