Study on Trastuzumab Deruxtecan for Previously Treated HER2-Negative Breast Cancer

Sponsor: Yale University

Sponsor score: 40

ClinicalTrials ID:NCT06750484

This clinical trial is testing the effects of a drug called trastuzumab deruxtecan (T-DXd) in adults with metastatic HER2-negative breast cancer to see who might benefit the most from this treatment.

Patient Parameters

Parameter	Options

Program Overview

The study aims to explore the benefits and side effects of trastuzumab deruxtecan (T-DXd) in patients with metastatic HER2-negative breast cancer. HER2 is a gene that can influence breast cancer growth. While traditional treatments target HER2-positive cancers, this study focuses on HER2-negative cases, which may still have low HER2 expression. T-DXd is a combination of a monoclonal antibody and an anticancer agent designed to target and kill cancer cells while sparing healthy ones. The study will assess how well T-DXd works in shrinking tumors and improving survival in these patients.

Description

Trastuzumab deruxtecan (T-DXd) is being tested in this study for its effectiveness in treating HER2-negative breast cancer that has spread or cannot be removed by surgery. HER2 is a gene that affects how breast cancer grows and responds to treatment. Although T-DXd is traditionally used for HER2-positive cancers, recent research suggests it may also benefit those with low HER2 expression. T-DXd combines a monoclonal antibody with an anticancer drug to target cancer cells specifically.

The study will measure how patients respond to T-DXd, including complete or partial tumor shrinkage, stable disease, or disease progression. Researchers will also look for markers that predict which patients will benefit most from T-DXd. The drug is already approved for use in adults with HER2-low breast cancer who have previously received chemotherapy.

Participants will receive T-DXd in 21-day treatment cycles. The study will help determine the safety and effectiveness of T-DXd in this patient group.

Eligibility Criteria

Inclusion Criteria

Must be able to understand and sign a consent form.
Adults aged 18 or older.
Have breast cancer that is metastatic or cannot be surgically removed.
Cancer must be HER2-negative and not previously treated with anti-HER2 therapy.
Have received 1 or 2 prior treatments for metastatic cancer.
Show disease progression on recent treatment.
Have a tumor sample available for testing.
Have at least one measurable tumor.
Be in good general health with specific blood and organ function levels.
Women must not be pregnant and must use effective birth control during and after the study.
Men must use condoms during and after the study.

Exclusion Criteria

Have significant heart disease or recent heart attack.
Have lung disease or inflammation that required steroids.
Have untreated or symptomatic brain metastases.
Have multiple cancers within the last 3 years, except certain skin or in situ cancers.
Have severe allergies to the study drug or similar drugs.
Have an uncontrolled infection.
Have unresolved side effects from previous cancer treatments.
Have had recent major surgery or radiation therapy.
Are pregnant or breastfeeding.
Are participating in another clinical trial or have recently received a live vaccine.

Locations

FACILITY	ZIP	CITY	STATE
Yale University	06511	New Haven	Connecticut

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.