OncoMatch/Clinical Trials/NCT05950945
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Is NCT05950945 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Trastuzumab Deruxtecan for breast cancer.
Treatment: Trastuzumab Deruxtecan — This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) IHC 1+ (IHC 1+)
Has confirmed HER2 IHC 1+ ... status as determined according to ASCO CAP 2018 guidelines
Required: HER2 (ERBB2) IHC 2+/ISH- (IHC 2+/ISH-)
Has confirmed HER2 IHC ... 2+/ISH- (HER2-low) status as determined according to ASCO CAP 2018 guidelines
Required: HER2 (ERBB2) IHC 0 (IHC 0)
Has confirmed HER2 ... IHC 0 status as determined according to ASCO CAP 2018 guidelines
Required: HER2 (ERBB2) wild-type
Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER2-targeted therapy
Exception: never previously treated with anti-HER2 therapy in the metastatic setting
Was never previously treated with anti-HER2 therapy in the metastatic setting
Cannot have received: antibody-drug conjugate
Prior treatment with an antibody drug conjugate (ADC)
Lab requirements
Blood counts
adequate organ and bone marrow function within 28 days before enrollment
Kidney function
adequate organ and bone marrow function within 28 days before enrollment
Liver function
adequate organ and bone marrow function within 28 days before enrollment
Cardiac function
left ventricular ejection fraction ≥50% within 28 days before enrollment; no uncontrolled or significant cardiovascular disease; no corrected QT interval prolongation
Has a left ventricular ejection fraction ≥50% within 28 days before enrollment. Has adequate organ and bone marrow function within 28 days before enrollment. Uncontrolled or significant cardiovascular disease. Has a corrected QT interval prolongation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mount Sinai Medical Center · Miami Beach, Florida
- USF College of Medicine · Tampa, Florida
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Beth Israel Lahey Health · Burlington, Massachusetts
- Overlook Medical Center · Summit, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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