Actively Recruiting
Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
Led by SCRI Development Innovations, LLC · Updated on 2026-03-20
36
Participants Needed
8
Research Sites
223 weeks
Total Duration
On this page
Sponsors
S
SCRI Development Innovations, LLC
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to: * Learn how well the combination of tucatinib and Doxil works * Learn more about the side effects of the combination of tucatinib and Doxil
CONDITIONS
Official Title
Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older
- ECOG Performance Status of 0 or 1
- Confirmed diagnosis of locally advanced or metastatic HER2 positive breast cancer
- Prior treatment with at least one anti-HER2 therapy for advanced disease or relapse within 6 months after adjuvant therapy
- Measurable disease per RECIST 1.1 criteria
- For females of childbearing potential, use of adequate contraception and negative pregnancy test prior to dosing
- Males with female partners of childbearing potential must use two forms of contraception during and 6 months after study
- Adequate blood counts: ANC ≥1500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL
- Adequate liver function: total bilirubin ≤1.5 x ULN (with exceptions), AST and ALT ≤2.5 x ULN or ≤5 x ULN if liver metastases
- Estimated glomerular filtration rate ≥50 mL/min/1.73 m2
- Left ventricular ejection fraction ≥50%
- Brain MRI showing no brain metastases, untreated brain metastases not needing immediate therapy, or stable previously treated brain metastases
- If CNS local therapy was recently given, minimum waiting periods met before starting treatment
- Other disease sites must be assessable by RECIST 1.1
You will not qualify if you...
- Systemic anti-cancer treatment within 21 days or 5 half-lives before study drugs, with at least 10 days since last dose
- Prior anthracycline treatment in any setting
- Major surgery within 28 days before study drugs (except vascular access placement)
- Palliative radiation therapy within 14 days before study drugs
- Untreated brain lesions >2.0 cm without Medical Monitor approval
- Use of systemic corticosteroids >2 mg dexamethasone daily for brain metastases symptoms (exceptions with approval)
- Brain lesions requiring immediate local therapy
- Known or suspected leptomeningeal disease
- Poorly controlled seizures or neurological progression from brain metastases
- Use of strong CYP2C8 or CYP3A4 inhibitors or CYP2C8 inducers within 5 days before treatment
- Unresolved toxicities from prior therapy above Grade 1 (except alopecia), unless stable and approved
- Pregnant or nursing women or plans to become pregnant during and 6 months after study
- Men planning to father a child during and 6 months after study
- Active gastrointestinal disease interfering with tucatinib absorption
- Significant cardiac abnormalities including prolonged QTc, heart block, or recent heart failure
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, diabetes, bleeding disorders, or active infections
- Known HIV infection or positive immunoassay
- Other active invasive cancers within 3 years except treated basal cell carcinoma, cervical carcinoma in situ, or cured local tumors
- Conditions preventing protocol compliance or follow-up
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Maryland Oncology Hematology
Columbia, Maryland, United States, 21044
Actively Recruiting
2
Alliance Cancer Specialists
Bensalem, Pennsylvania, United States, 19020
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
5
Texas Oncology- DFW
Dallas, Texas, United States, 75246
Actively Recruiting
6
Texas Oncology- San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
7
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
8
Blue Ridge Cancer Care (Oncology & Hematology Assoc of SW Virginia, Inc)
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
S
Sarah Cannon Development Innovations
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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