An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus in First to Third Line LAR Subtype TNBC

Sponsor
Fudan University
Study ID
NCT07760844
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • SHR- A1811+ eve — DRUG
    SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle. Everolimus administered at a fixed dose of 5 mg orally, once daily, continuously.
  • SHR- A1811 — DRUG
    SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle

Study Details

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the LAR subtype. A total of 180 patients are planned to be enrolled.

Key Dates

First listed
Aug 12, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm-A
    SHRA1811 at 4.8 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle. Everolimus administered at a fixed dose of 5 mg orally, once daily, continuously.
  • Active Comparator: Arm-B
    SHRA1811 at 4.8 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.

Primary Outcome Measure

Progression Free Survival(PFS) [ Time Frame: 24 months ]

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