Tucatinib+Trastuzumab+Eribulin in HER2+ MBC

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Criterium, Inc.
Study ID
NCT05458674
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tucatinib — DRUG
    taken orally
  • Eribulin — DRUG
    taknen intravenously
  • Trastuzumab — DRUG
    taken intravenously

Study Details

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.

Key Dates

Start date
Jan 30, 2024
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tucatinib/Eribulin/Trastuzumab
    * The initial dose of trastuzumab will be given as a loading dose of 8 mg/kg intravenously (IV), unless trastuzumab was administered within the prior 4 weeks, then the initial dose of trastuzumab will be administered at a dose of 6 mg/kg. Each trastuzumab dose is given once every 21 days, except in specific circumstances where it may be given weekly to compensate for modifications in treatment schedule * Tucatinib 300 mg orally twice daily (PO BID) every day (Days 1-21) of each 21-day cycle using a modified schedule of events. Subcutaneous trastuzumab is given only once every three weeks as there is no allowance for weekly dosing. * Eribulin will be given at a dose of 1.1 mg/M2 intravenously over a 2-5 minute period on days 1 and 8 of each 21-day cycle.

Primary Outcome Measure

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. [ Time Frame: 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Luke Deegan
[email protected]
303-724-9905
Virginia F Borges, MD (PRINCIPAL_INVESTIGATOR)
George Washington Medical Faculty AssociatesWashington D.C.District of Columbia20037
Alyssa Barnett
[email protected]
202-994-0246
Pavani Chalasani, MD, MPH (PRINCIPAL_INVESTIGATOR)
New Mexico Cancer Care AllianceAlbuquerqueNew Mexico87131
Jacklyn Nemunaitis
[email protected]
Jacklyn Nemunaitis, MD (PRINCIPAL_INVESTIGATOR)
Swedish Cancer InstituteIssaquahWashington98029
Laurissa Aravena
[email protected]
425-351-9129
Kinsey A McCormick, MD (PRINCIPAL_INVESTIGATOR)
Cancer Care NorthwestSpokane ValleyWashington99216
Anthony Grimmett
[email protected]
509-228-1680
Saritha Thumma, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Ashley Rohm
[email protected]
509-228-1688
Kari Wisinski, MD (PRINCIPAL_INVESTIGATOR)

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University of Colorado· Aurora, COGeorge Washington Medical Faculty Associates· Washington D.C., DCNew Mexico Cancer Care Alliance· Albuquerque, NMSwedish Cancer Institute· Issaquah, WACancer Care Northwest· Spokane Valley, WAUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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