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 (Jun 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
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT05748834 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anthracycline disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
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 qualifyRelated pages