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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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⁃ Eligibility Criteria:

• Female patients aged 18 to 70 years.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Histologically confirmed HR-positive/HER2-negative breast cancer (defined as: (1) ER-positive: ≥10% tumor cells positive by immunohistochemistry (IHC).

⁃ (2) PR-positive: ≥10% tumor cells positive by IHC. (3) HR-positive: ER and/or PR positive. (4) HER2-negative: HER2 0-1+ by IHC or HER2 2+ with negative FISH (no amplification).

⁃ 4\. Confirmed SNF2/3/4 subtype based on H\&E staining combined with digital pathology molecular subtyping.

⁃ 5\. Clinical tumor stage: cT1c-T2, cN1-N2 or cT3-T4, cN0-N2. 6. Agreement to undergo breast cancer surgery if meeting the criteria for resection after neoadjuvant therapy.

⁃ 7\. Adequate organ function, meeting the following criteria: Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥75×10⁹/L; Total bilirubin (TBIL) ≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; Serum creatinine (Cr) ≤1×ULN; Creatinine clearance rate (CrCl) \>50 mL/min (calculated by Cockcroft-Gault formula).

⁃ 8\. Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiography or MUGA scan.

⁃ 9\. Negative serum pregnancy test for women of childbearing potential. Contraception requirement: Women of childbearing potential must use medically approved contraception during treatment and for at least 3 months after the last dose of the study drug.

⁃ 10Voluntary participation with signed informed consent, good compliance, and willingness to follow up.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Zhimin Shao, MD, PhD
zhi_ming_shao@163.com
+86-021-64175590
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2027-04-15
Participants
Target number of participants: 404
Treatments
Active_comparator: Control
chemotherapy (wP-EC)
Experimental: Precision group
chemotherapy + target therapy
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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