HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Memorial Sloan Kettering Cancer Center
Summary
Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC. * Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8. * HER2 IHC results of 3+. * Life expectancy of ≥12 weeks. * Must be deemed medically fit for surgery and be surgical candidates upfront, or potentially operable if there is response to induction therapy. * Must have measurable disease per PERCIST 1.0. * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. * Ha…