Tucatinib+Trastuzumab+Eribulin in HER2+ MBC (NCT05458674)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (24 items) and avoid the listed exclusions (36 items).
Location: University of Colorado — Aurora, Colorado
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
- History of exposure to the following cumulative doses of anthracyclines:
- Doxorubicin \> 360 mg/m2
- Epirubicin \> 720 mg/m2
- Mitoxantrone \> 120 mg/m2
- Idarubicin \> 90 mg/m2
- Liposomal doxorubicin (e.g. Doxil, Caelyx, Myocet) \> 550 mg/m2
- 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
- Have received treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial. An exception for the washout of hormonal therapies is gonadotropin releasing hormone (GnRH) agonists used for ovarian suppression in premenopausal women, which are permitted concomitant medications.
- Have any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
- alopecia and neuropathy, which must have resolved to ≤ Grade 2; and
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 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
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.