Actively Recruiting
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
Led by Criterium, Inc. · Updated on 2026-04-03
30
Participants Needed
6
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed HER2-positive breast cancer defined by ISH, FISH, or IHC
- Previous treatment with trastuzumab deruxtecan in metastatic setting or recurrence within 6 months after adjuvant/neoadjuvant treatment
- Measurable or non-measurable disease assessable by RECIST 1.1
- Age 18 years or older at consent
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 6 months
- Adequate liver function with bilirubin and transaminase levels within defined limits
- Adequate blood counts with specified neutrophil, platelet, and hemoglobin levels
- Creatinine clearance of at least 50 mL/min or normal serum creatinine if weight ≤45 kg
- INR and aPTT within 1.5 times upper limit of normal unless on allowed medications
- Left ventricular ejection fraction of 50% or higher within 4 weeks before treatment
- Negative pregnancy test within 7 days prior to first dose for women of childbearing potential
- Use of effective birth control methods for women of childbearing potential and men with partners of childbearing potential
- Signed informed consent prior to study procedures
- Willingness and ability to comply with study procedures
- Brain MRI showing either no brain metastases, untreated brain metastases not requiring immediate therapy, or previously treated brain metastases stable or not needing immediate re-treatment
You will not qualify if you...
- Previous eribulin treatment for metastatic disease except brief use (<21 days) not due to progression or severe toxicity
- History of high cumulative doses of anthracyclines above specified limits
- Allergic reactions to trastuzumab, eribulin, tucatinib, or related compounds except mild infusion reactions
- Systemic cancer therapy, radiation, or experimental treatment within 3 weeks before study or current participation in another trial (some hormonal therapies allowed)
- Unresolved toxicity from prior therapies above specified grades except certain alopecia, neuropathy, heart failure, and anemia
- Significant heart or lung disease including arrhythmias, uncontrolled hypertension, symptomatic heart failure, severe resting shortness of breath, need for oxygen except sleep apnea, or QTc prolongation
- Myocardial infarction or unstable angina within 6 months
- Chronic active hepatitis B or C or other chronic liver disease
- HIV positive status
- Pregnancy, breastfeeding, or planning pregnancy
- Need for warfarin or coumarin anticoagulants
- Inability to swallow pills or significant gastrointestinal disease preventing medication absorption
- Use of strong CYP3A4 or CYP2C8 inhibitors or inducers near start of study
- Inability to undergo contrast brain MRI
- Other medical, social, or psychosocial issues affecting safety or compliance
- Another malignancy requiring systemic treatment within 2 years
- Brain MRI showing untreated brain lesions >2.0 cm without approval, ongoing high-dose corticosteroid use for brain metastases symptoms, brain lesions needing immediate local therapy, or poorly controlled seizures or neurological progression due to brain metastases
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
3
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
4
Swedish Cancer Institute
Issaquah, Washington, United States, 98029
Actively Recruiting
5
Cancer Care Northwest
Spokane Valley, Washington, United States, 99216
Actively Recruiting
6
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
B
Bebi Yassin-Rajkumar
CONTACT
J
James Zemer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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