T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients

Sponsor
Fudan University
Study ID
NCT05953168
Phase
PHASE2
Status
Unknown

Conditions

  • Triple-Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    Trastuzumab Deruxtecan for TNBC-LAR patients with HER2 low expression

Study Details

This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype (TNBC-LAR) with low HER2 expression.

Key Dates

First listed
Jul 19, 2023
Start date
Aug 31, 2023
Status verified
Jul 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2026

Study Design

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

Arms

  • Experimental: Trastuzumab Deruxtecan (T-DXd)

Primary Outcome Measure

Objective Response of Complete Response (ORR) [ Time Frame: 3 years (assessed at Screening, every 6 weeks for the first 12 months, thereafter every 9 weeks until disease progression or death, whichever occurs first) ]

Central Contacts

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