RecruitingPhase 2

Trial of Trastuzumab Deruxtecan in Previously Treated HER2

United States40 participantsStarted 2025-06-20

Plain-language summary

The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) approved ICF before performance of any study-specific procedures or tests.
✓. Men or women ≥18 years old.
✓. Pathologically documented breast cancer that is unresectable or metastatic.
✓. 4.Tumor biopsies have always shown HER2-IHC 0 (\<10% membrane staining, including 0 null and 0 ultralow) in all prior biopsies and never previously HER2-positive (IHC 3+ or ISH+) or HER2-low (1+, or 2+ ISH-) on prior pathology testing according to American Society of Clinical Oncology College of American Pathologists (ASCO-CAP) guidelines.
✓. Either HR-positive or HR-negative status of the tumor per ASCO-CAP guidelines are allowed.
✓. Patients with HR-positive disease must have progressed or be intolerant to CDK 4/6 inhibitors plus endocrine therapy, and patients with HR-negative disease must have received 1 line of therapy in the metastatic setting (progression on or within 6 months of neoadjuvant or adjuvant therapy will be accounted for as 1 line of prior therapy). There is no limit on number of subsequent lines of therapy for study entry. .
✓. Patients must have never been previously treated with any anti-HER2 therapy, including prior trastuzumab deruxtecan, other HER2-directed ADCs, HER2 antibodies or HER2 tyrosine kinase inhibitors
✓. Clinical or radiologic progression (during or after most recent treatment) or intolerance to therapy prior to enrollment in this trial

Exclusion criteria

✕. Uncontrolled or significant cardiovascular disease, including any of the following:
✕. History of myocardial infarction within 6 months before enrolment.
✕. History of symptomatic congestive heart failure (New York Heart Association Class II to IV).
✕. Corrected QT interval (QTc) Fridericia prolongation to \>470 ms (females) or \>450 ms (male) based on average of Screening 12 lead ECG.
✕. Uncontrolled or significant respiratory disease criteria, including any of the following:
✕. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
✕. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, symptomatic, recurrent and uncontrolled pleural effusion etc.)
✕. Any autoimmune, connective tissue or inflammatory disorders, including Rheumatoid arthritis, Sjogren's, and sarcoidosis, where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for participants who are included in the study.

What they're measuring

Objective Response Rate

Timeframe: After cycle 3, approximately 63 days

Trial details

NCT IDNCT06750484

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Laura Kane

773-369-6904 laura.kane@yale.edu

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