OncoMatch/Clinical Trials/NCT05748834
Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
Is NCT05748834 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tucatinib and Doxil for breast cancer.
Treatment: Tucatinib · Doxil — This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to: * Learn how well the combination of tucatinib and Doxil works * Learn more about the side effects of the combination of tucatinib and Doxil
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or fish+)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy — locally advanced/metastatic or relapsed within 6 months of completion of adjuvant anti-HER2 therapy
prior treatment with at least 1 line of anti-HER2 therapy for locally advanced/metastatic disease or relapsed within 6 months of completion of adjuvant anti-HER2 therapy
Cannot have received: anthracycline
Prior treatment with anthracycline in any setting
Lab requirements
Blood counts
ANC ≥1500/µL; Platelet count ≥100,000/µL (no transfusions allowed); Hemoglobin ≥9 g/dL (at least 2-week washout from any transfusion)
Kidney function
eGFR ≥50 mL/min/1.73 m2
Liver function
Total bilirubin ≤1.5 × ULN (exception: Gilbert's Syndrome with direct bilirubin ≤1.5 × ULN and normal AST/ALT); AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastases present)
Cardiac function
LVEF ≥50% based on screening ECHO/MUGA; QTcF ≤480 msec for females and ≤460 msec for males in three successive screening measures; no clinically important ECG abnormalities; no NYHA ≥ Grade 2 CHF within past 6 months
Adequate hematologic function... Adequate hepatic function... Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2... Left ventricular ejection fraction (LVEF) ≥50%... cardiac criteria: QTcF prolongation to >480 msec for females and >460 msec for males in three successive screening measures; any clinically important ECG abnormalities; congestive heart failure (NYHA ≥ Grade 2 within past 6 months); LVEF <50% or lower limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Maryland Oncology Hematology · Columbia, Maryland
- Alliance Cancer Specialists · Bensalem, Pennsylvania
- SCRI Oncology Partners · Nashville, Tennessee
- Tennessee Oncology · Nashville, Tennessee
- Texas Oncology- DFW · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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