OncoMatch/Clinical Trials/NCT05458674
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
Is NCT05458674 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tucatinib and Eribulin for breast cancer.
Treatment: Tucatinib · Eribulin · Trastuzumab — The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, trastuzumab, and T-DM1.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression/amplification (positive by ISH/FISH or IHC)
HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antibody-drug conjugate (HER2-targeted) (trastuzumab deruxtecan) — metastatic OR adjuvant/neoadjuvant with recurrence within 6 months
Have received previous treatment with trastuzumab deruxtecan in the metastatic setting or have recurred within 6 months of receiving this treatment in the adjuvant or neoadjuvant setting
Cannot have received: eribulin (eribulin)
Exception: if given for ≤21 days and discontinued for reasons other than disease progression or severe toxicity
Have previously been treated with eribulin for metastatic disease (except in cases where eribulin was given for ≤ 21 days and was discontinued for reasons other than disease progression or severe toxicity)
Lab requirements
Blood counts
ANC ≥1.5 x 10^3/µL; Platelet count ≥100 x 10^3/µL (stable 75-100 may be allowed with medical monitor approval); Hemoglobin ≥9 g/dL; transfusion ≥14 days prior if applicable
Kidney function
Creatinine clearance ≥50 mL/min (or serum creatinine within normal limits if ≤45 kg)
Liver function
Total bilirubin ≤1.5 X ULN (except Gilbert's disease with conjugated bilirubin ≤1.5 X ULN); AST/ALT ≤2.5 X ULN (≤5 X ULN if liver metastases present)
Cardiac function
LVEF ≥50% by ECHO or MUGA within 4 weeks prior
Have adequate hepatic function as defined by the following: Total bilirubin ≤1.5 X ULN, except for patients with known Gilbert's disease, who may enroll if the conjugated bilirubin is ≤1.5 X ULN; Transaminases [AST and ALT] ≤ 2.5 X ULN (≤ 5 X ULN if liver metastases are present). Have adequate baseline hematologic parameters as defined by: ANC ≥ 1.5 x 10^3/µL; Platelet count ≥ 100 x 10^3/µL; patients with stable platelet count from 75- 100 x 10^3/µL may be included with approval from medical monitor; Hemoglobin ≥ 9 g/dL; In patients transfused before study entry, transfusion must be ≥ 14 days prior to start of therapy to establish adequate hematologic parameters independent from transfusion support. Have creatinine clearance ≥ 50 mL/min as calculated per institutional guidelines or, in patients ≤ 45 kg in weight, a serum creatinine within institutional normal limits. Have left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado · Aurora, Colorado
- George Washington Medical Faculty Associates · Washington D.C., District of Columbia
- New Mexico Cancer Care Alliance · Albuquerque, New Mexico
- Swedish Cancer Institute · Issaquah, Washington
- Cancer Care Northwest · Spokane Valley, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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