Tucatinib+Trastuzumab+Eribulin in HER2+ MBC (NCT05458674) | Clinical Trial Compass
RecruitingPhase 2
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
United States30 participantsStarted 2024-01-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC)
✓. 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. Prior taxane, capecitabine and T-DM1 are not required. Prior tucatinib therapy is allowed. Patients for whom Trastuzumab is contraindicated are not permitted. Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by site investigator),or be intolerant of last systemic therapy.
✓. Have measurable or non-measurable disease assessable by RECIST 1.1
✓. Be at least 18 years of age at time of consent.
✓. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0,1 or 2
✓. Have a life expectancy of at least 6 months, in the opinion of the site investigator.
✓. Have adequate hepatic function as defined by the following:
✓. Total bilirubin ≤1.5 X upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if the conjugated bilirubin is ≤1.5 X ULN
Exclusion criteria
✕. 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)
What they're measuring
1
To assess the safety and tolerability of tucatinib in combination with eribulin and trastuzumab in patients with unresectable or recurrent metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, and trastuzumab deruxtecan.
Timeframe: 2 years
2
Evaluate the relative toxicity/tolerability of these therapeutic agents when used in combination in this patient cohort
✕. History of allergic reactions to trastuzumab, eribulin, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the study drugs