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

Sponsor
Fudan University
Study ID
NCT07669610
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 — DRUG
    SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle.
  • SHR-A1811+BEV — DRUG
    SHRA1811(HER-targeted ADC) at 4.8 mg/kg in combination with BEV(bevacizumab) at 15 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment 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 BLIS subtype. A total of 140 patients are planned to be enrolled.

Key Dates

First listed
Jun 25, 2026
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Mar 30, 2029

Study Design

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

Arms

  • Experimental: Arm-A
    SHRA1811 at 4.8 mg/kg in combination with BP102 at 15 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.
  • 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 ]

Central Contacts

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