What is tucatinib studying for HER2-positive metastatic breast cancer?

Tucatinib is being studied in combination with Doxil to evaluate its anti-tumor activity and safety in people with HER2-positive metastatic breast cancer. Researchers want to understand how well this combination works and learn about possible side effects. The study is sponsored by SCRI Development Innovations, LLC.

Who may be eligible for this breast cancer clinical trial?

Adults aged 18 or older with confirmed HER2-positive locally advanced or metastatic breast cancer who have had at least one prior anti-HER2 therapy may be eligible. Participants must have good overall health with an ECOG performance status of 0 or 1 and meet certain lab and imaging requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05748834

Phase 2 Study Evaluating Tucatinib and Doxil Combination for HER2 Positive Metastatic Breast Cancer

Led by SCRI Development Innovations, LLC · Updated on 2026-03-20

Participants Needed

Research Sites

N/A

Total Duration

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 mgm2 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

Age: 18Years +

All Genders

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

Research Team

Sarah Cannon Development Innovations

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Phase 2 Study Evaluating Tucatinib and Doxil Combination for HER2 Positive Metastatic Breast Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria