At a glance
ClinicalIndex Comparison Record- ✓Confirmed HER2+ breast cancer by ASCO/CAP guidelines at CLIA/ISO-certified lab
- ✓Prior taxane and trastuzumab in metastatic/locally-advanced setting OR progression within 6 months of neoadjuvant/adjuvant treatment with taxane and trastuzumab
- ✓Progression of unresectable locally-advanced/metastatic breast cancer after last systemic therapy OR intolerance of last systemic therapy
- ✓Measurable disease by RECIST v1.1
- ✕Prior treatment with lapatinib or neratinib within 12 months (except if given ≤21 days for reasons other than progression or severe toxicity)
- ✕Prior treatment with tucatinib or enrolled in tucatinib clinical trial
- ✕Any prior investigational HER2/EGFR or HER2 TKI (e.g., afatinib)
- ✕Prior treatment with trastuzumab deruxtecan or another ADC with exatecan derivative
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer
In Brief
A Phase 2 clinical trial evaluating tucatinib and trastuzumab deruxtecan for HER2 Positive Breast Cancer. Completed, enrolled 70 participants across 140 sites.
Detailed Summary
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.
Study Details
Timeline
Interventions
300 mg orally twice daily
5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle