RecruitingPhase 3NCT06913777

Neoadjuvant SNF Precision Therapy Phase III

An Open-Label, Multicenter, Randomized Controlled Phase III Clinical Study of Neoadjuvant Chemotherapy Based on SNF Classification With or Without Precision Medicine Agents for Early-Stage or Locally Advanced HR+/HER2- Breast Cancer

Sponsor

Fudan University

Enrollment

404 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized neoadjuvant (pre-surgery) treatment program — using precision molecular subtypes to tailor chemotherapy — for women with hormone receptor-positive, HER2-negative breast cancer before surgery. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have hormone receptor-positive, HER2-negative breast cancer confirmed by biopsy - Your cancer has been classified into a specific molecular subtype (SNF2/3/4) based on tissue analysis - Your cancer is at stage cT1c-T2 with lymph node involvement, or stage cT3-T4 - You are willing to have breast surgery if the tumor responds well to neoadjuvant therapy - Your heart, blood, and organ function meet the required thresholds **You may NOT be eligible if...** - You have stage IV (metastatic) breast cancer - You have a history of invasive breast cancer or certain pre-cancerous breast conditions - You have previously received systemic treatment for breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTargeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib

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.

DRUGChemotherapy (wP-EC)

Chemotherapy : weely nab-P \* 12- EC \* 4