Neoadjuvant SNF Precision Therapy Phase III

NCT06913777 | Recruiting Phase 3 DMC

• 1 other identifier: SCHBCC-N090
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  pCR rate after neoadjuvant treatment, defined as the proportion of participants who have no evidence by H\&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by investigator assessment following completion of neoadjuvant therapy.

  Up to approximately 1 year

Secondary Outcomes (5)

• Event-free survival (EFS) rate at 12, 24, 36-month

  Up to approximately 3 years

• Invasive disease-free survival (IDFS) rate at 12, 24, 36-month

  Up to approximately 3 years

• Overall Survival (OS)

  Approximately 5 years

• Objective Response Rate (ORR)

  Approximately 1 year

• Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).

  Up to approximately 1.5 years

Study Arms (2)

Control

ACTIVE COMPARATOR

chemotherapy (wP-EC）

Drug: Chemotherapy (wP-EC)

Precision group

EXPERIMENTAL

chemotherapy + target therapy

Drug: Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib; Drug: Chemotherapy (wP-EC)

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.

Precision group

Chemotherapy (wP-EC) DRUG

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

Control; Precision group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Stage IV (metastatic) breast cancer.
• History of invasive breast cancer.
• History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
• Prior systemic therapy for breast cancer (chemotherapy, endocrine therapy, or anti-HER2 therapy), or prior excisional biopsy/radiotherapy of primary breast tumor and/or axillary lymph nodes (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors).
• Other malignancies within the past 5 years (except cured cervical carcinoma in situ or non-melanoma skin cancer).
• Participation in any other investigational drug study within 4 weeks prior to randomization.
• Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0).
• Severe cardiovascular or cerebrovascular diseases within 6 months prior to randomization, including but not limited to:
• Congestive heart failure,
• Unstable angina,
• Severe uncontrolled arrhythmias,
• Clinically significant valvular disease,
• Uncontrolled severe hypertension,
• Myocardial infarction, or
• Cerebrovascular accident.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

famitinib; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhi_ming_shao@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)