Neoadjuvant SNF Precision Therapy Phase III

Sponsor
Fudan University
Study ID
NCT06913777
Phase
PHASE3
Status
Recruiting
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Conditions

  • Neoadjuvant Therapy

Eligibility Criteria

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

Interventions

  • Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib — DRUG
    The backbone is chemotherapy which will be used in the control group. The precision group will add targeted therapy agents which were determined according to SNF classification: the SNF2 subtype add adebrelimab combined with famitinib, the SNF3 subtype receives fluzoparib, and the SNF4 subtype receives apatinib.
  • Chemotherapy (wP-EC) — DRUG
    Chemotherapy : weely nab-P \* 12- EC \* 4

Study Details

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.

Key Dates

Start date
Apr 8, 2025
Status verified
Jun 2025
Primary completion
Oct 15, 2026
Completion
Apr 15, 2027

Study Design

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

Arms

  • Active Comparator: Control
    chemotherapy (wP-EC）
  • Experimental: Precision group
    chemotherapy + target therapy

Primary Outcome Measure

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery) [ Time Frame: Up to approximately 1 year ]

Central Contacts