Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer

Sponsor
Xijing Hospital
Study ID
NCT07466303
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Breast Cancer
  • Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer

Eligibility Criteria

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

Interventions

  • Serplulimab — DRUG
    Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting.
  • SHR-A1811 — DRUG
    Administered intravenously at a protocol-specified dose, once every 3 weeks (Q3W), for a total of 6 cycles in the neoadjuvant setting.

Study Details

To evaluate the efficacy and safety of Serplulimab in combination with Trastuzumab Restuzumab for the neoadjuvant treatment of triple-negative breast cancer, aiming to provide evidence for optimizing the strategy of combining immunotherapy with ADC drugs in the neoadjuvant setting.

Key Dates

Start date
Mar 25, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Apr 1, 2031

Study Design

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

Arms

  • Experimental: Neoadjuvant Serplulimab + SHR-A1811
    All enrolled participants will receive the investigational combination therapy as neoadjuvant treatment. This regimen consists of Serplulimab (an anti-PD-1 monoclonal antibody) and SHR-A1811 (Trastuzumab Restuzumab , an antibody-drug conjugate). Both agents are administered intravenously every 3 weeks (Q3W) for 6 cycles prior to definitive surgery. The primary objective is to evaluate the efficacy and safety of this chemotherapy-free combination in patients with early-stage triple-negative breast cancer (TNBC).

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: At the time of definitive surgery (after 6 cycles of neoadjuvant therapy; each cycle is 21 days). ]

Central Contacts

Related Studies