OncoMatch/Clinical Trials/NCT05458674
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
Is NCT05458674 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT05458674 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior eribulin disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression/amplification 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