Trial of Trastuzumab Deruxtecan in Previously Treated HER2

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06750484
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    Participants will receive the study drug trastuzumab deruxtecan (T-DXd) by IV infusion every 21 days. The number of treatment cycles will depend on how participants respond to treatment.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab Deruxtecan
    T-DXd will be administered intravenously every 3 weeks at a dose of 5.4 mg per kilogram of body weight until disease progression, limiting toxicity, withdrawal of consent, or death. For T-DXd, each cycle of treatment will be 21 days. The number of treatment cycles with T-DXd is not fixed.

Primary Outcome Measure

Objective Response Rate [ Time Frame: After cycle 3, approximately 63 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Carl Brown
[email protected]
203-785-4095
Adriana Kahn, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642
Ildiko Nagy
[email protected]
585-275-5863
Ruth O'Regan, MD (PRINCIPAL_INVESTIGATOR)

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