OncoMatch/Clinical Trials/NCT07371585
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
Is NCT07371585 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Digital Health Tools and T-DXd for breast cancer stage iv.
Treatment: Digital Health Tools · T-DXd · Pertuzumab — This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD/pneumonitis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression or amplification (HER2-positivity confirmed in a tumor sample obtained in the metastatic setting, defined as either IHC 3+ or in situ hybridization positive (ISH+)) (IHC 3+ or ISH+)
HER2-positivity confirmed in a tumor sample obtained in the metastatic setting, defined as either IHC 3+ or in situ hybridization positive (ISH+) by local laboratory assessment
Allowed: ESR1 expression >1% of cells (ER positivity)
ER and/or PR positivity is defined as >1% of cells expressing HR via IHC analysis
Allowed: PR (PGR) expression >1% of cells (PR positivity)
ER and/or PR positivity is defined as >1% of cells expressing HR via IHC analysis
Disease stage
Required: Stage III, IV
Metastatic disease required
locally advanced disease, not amenable to resection or radiation therapy with curative intent, or metastatic disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy — metastatic
1 prior line of endocrine therapy is allowed for mBC
Cannot have received: chemotherapy
Exception: chemotherapy in the neoadjuvant or adjuvant setting at any time is allowed
No prior chemotherapy for advanced or mBC
Cannot have received: HER2-targeted therapy
Exception: HER2-targeted therapy in the neoadjuvant or adjuvant setting at any time is allowed
No prior HER2-targeted therapy for advanced or mBC
Cannot have received: antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor)
Exception: must have a disease-free interval of ≥12 months since the last dose if received in the adjuvant setting
Patients that received an antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor) in the adjuvant setting, must have a disease-free interval of ≥12 months since the last dose
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
LVEF ≥ 50% within 28 days before Cycle 1 Day 1
Adequate hematologic and end-organ function, defined by the following laboratory results (see protocol). LVEF ≥ 50% within 28 days before Cycle 1 Day 1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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