OncoMatch/Clinical Trials/NCT07371585
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
Is NCT07371585 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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.
Frequently asked questions
Is NCT07371585 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, 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+)) is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify