Actively Recruiting
Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for HER2+ Metastatic Breast Cancer
Led by SCRI Development Innovations, LLC · Updated on 2026-03-20
36
Participants Needed
8
Research Sites
N/A
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
Researchers are evaluating the combination of tucatinib with Doxil in participants who have HER2-positive locally advanced or metastatic breast cancer. This Phase 2, open-label study focuses on understanding how well this treatment works and learning about its side effects in patients who have already received at least one prior anti-HER2 therapy. Participants will receive tucatinib orally at 300 mg twice daily continuously in 28-day cycles, along with Doxil given intravenously at 40 mg/m2 on the first day of each cycle. The study begins with a safety lead-in phase for the first 6 patients monitored weekly for 28 days to check tolerability. If no severe toxicities occur, enrollment will continue up to 36 participants. Throughout the study, researchers will assess tumor response using RECIST v1.1 criteria over roughly 40 months. They will also monitor side effects, progression-free survival, and other health measures. Participants will undergo regular clinical evaluations, imaging scans, and lab tests. Safety will be closely tracked during treatment and for 30 days after the last dose, with follow-up visits scheduled as needed.
CONDITIONS
Brief 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
- At least 18 years old at consent
- ECOG performance status of 0 or 1
- Confirmed diagnosis of locally advanced/metastatic HER2+ breast cancer per ASCO/CAP guidelines
- Prior treatment with at least one anti-HER2 therapy for advanced disease or relapse within 6 months of adjuvant therapy
- Measurable disease by RECIST 1.1
- Females of child-bearing potential must use contraception, not breastfeed, and have a negative pregnancy test or meet criteria for non-child-bearing potential
- Males with female partners of childbearing potential and females of childbearing potential must use two forms of contraception and males must avoid sperm donation during and 6 months after treatment
- Adequate blood counts including ANC ≥1500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL
- Adequate liver function with bilirubin ≤1.5 × ULN, AST and ALT ≤2.5 × ULN (or ≤5 × 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 treated brain metastases stable or progressing without need for immediate local therapy
- Time from CNS therapies as specified if applicable
- Other measurable disease sites present
You will not qualify if you...
- Use of systemic anti-cancer therapies within 21 days or 5 half-lives before first study dose; at least 10 days must have passed since last dose
- Prior anthracycline treatment
- Major surgery within 28 days before first study dose (except vascular access)
- Palliative radiation therapy within 14 days before first study dose
- Untreated brain lesions >2.0 cm without Medical Monitor approval
- Use of systemic corticosteroids >2 mg dexamethasone daily unless stable dose ≤2 mg approved
- Brain lesions requiring immediate local therapy
- Known or suspected leptomeningeal disease
- Poorly controlled seizures or neurologic progression from brain metastases
- Use of strong CYP2C8 or CYP3A4 inhibitors or inducers within 5 days before first dose
- Unresolved toxicities > Grade 1 from prior therapy except alopecia unless approved
- Pregnant or nursing women or planning pregnancy during study and 6 months after
- Men planning to father a child during study and 6 months after
- Active gastrointestinal disease affecting drug absorption
- Certain cardiac abnormalities or heart failure within 6 months
- Severe or uncontrolled systemic diseases
- Known HIV infection or positive immunoassay unless previously documented
- Other active invasive cancers within 3 years except certain treated local tumors
- Conditions preventing protocol compliance or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
The first 6 participants will be monitored weekly for one 28-day treatment cycle to evaluate safety and tolerability of the drug combination.
Weekly visits for 4 weeks
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive tucatinib by mouth twice daily continuously and Doxil intravenously on day 1 of each 28-day cycle. Treatment continues with cycles of 28 days until discontinuation.
1 visit per 28-day cycle (in-person)
Duration - Up to approximately 40 months
Participants are monitored for adverse events and progression-free survival for up to approximately 40 months after treatment ends.
Visits as needed for safety and disease assessment
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
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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