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.
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.
Patients diagnosed with HER2+ breast cancer as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH
Prior exposure to anti-HER2 therapy of any kind or any systemic anti-cancer treatment of any kind for breast cancer.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses >10 mg daily of oral prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Inhaled, intranasal, intra-articular, or topical steroid use are allowed.
Single group
Personalis NeXT Personal
Diagnostic testThe use of this assay is expected to optimize treatment without introducing significant new risks or deviating from approved therapeutic protocols.
Natera Signatera
Diagnostic testThe use of this assay is expected to optimize treatment without introducing significant new risks or deviating from approved therapeutic protocols.
fam-trastuzumab deruxtecan-nxki (T-DXd)
DrugT-DXd is a HER2-targeting antibody drug conjugate that consists of an anti-HER2 antibody.
pertuzumab, called T-DXd+P
Drugintravenous (IV) infusion
Proportion of participants who maintain Complete Response/CR and Molecular Complete Response/mCR
To evaluate the proportion of participants who maintain CR and mCR for 12 months from initiation of the maintenance/surveillance phase.
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