Actively Recruiting
An Open-label, Randomized Study Comparing Patritumab Deruxtecan Versus Physicians Choice in Treating Hormone Receptor-positive, HER2-negative Advanced or Metastatic Breast Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
1000
Participants Needed
182
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for hormone receptor-positive, HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on patients whose cancer has either locally advanced or metastatic disease and have previously received specific hormone and targeted therapies. The goal is to see if treatment with patritumab deruxtecan can help patients live longer or delay cancer progression compared to other chemotherapy options or trastuzumab deruxtecan. Participants are randomly assigned to receive either patritumab deruxtecan through intravenous infusion every three weeks for about 13 months or a treatment chosen by their doctor, which may include various chemotherapy drugs or trastuzumab deruxtecan. The study treatment options in the doctors choice group are given on different schedules, such as weekly or every three to four weeks, depending on the drug selected. Throughout the study, participants will be closely monitored with regular assessments to measure progression-free survival and overall survival for up to approximately 45 and 85 months respectively. Researchers will also evaluate tumor response, quality of life using specific questionnaires, and track any side effects. The study includes long-term follow-up to understand the impact of treatment over time and ensure participant safety.
CONDITIONS
Brief Title
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with hormone receptor-positive (HR+) and HER2-negative (HER2-) invasive breast cancer that is unresectable locally advanced or metastatic
- Centrally confirmed HR+ and HER2- status and evaluable HER3 results from a recent biopsy
- Progression or recurrence after treatment with CDK4/6 inhibitor plus endocrine therapy
- Measurable disease per RECIST 1.1 criteria
- Well-controlled HIV infection if present
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization
You will not qualify if you...
- Breast cancer that can be treated with curative intent
- Eligible for additional endocrine therapy in the advanced setting
- Known harmful BRCA gene mutation where PARP inhibitors are a treatment option
- Current or impending visceral crisis causing organ compromise or life-threatening conditions
- Pulse oximetry reading below 92% at rest or need for supplemental oxygen
- Uncontrolled significant cardiovascular or cerebrovascular disease
- Peripheral neuropathy of grade 2 or higher
- Clinically significant corneal disease
- Previous chemotherapy for unresectable locally advanced or metastatic breast cancer
- Prior treatment with anti-HER3 antibody-drug conjugates or topoisomerase I inhibitors
- Recent systemic anticancer therapy within 4 weeks before randomization
- Recent radiotherapy for non-central nervous system disease within 14 days before study treatment
- Immunodeficiency or ongoing systemic steroid therapy
- Active additional malignancy requiring treatment within the past 3 years
- History or current pneumonitis/interstitial lung disease requiring steroids or suspected but unconfirmed by imaging
- Severe hypersensitivity to patritumab deruxtecan or any treatment of physician's choice agents or their components
Research Team
T
Toll Free Number
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here