Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT06913777

Neoadjuvant SNF Precision Therapy Phase III

Led by Fudan University · Updated on 2025-06-06

404

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Neoadjuvant SNF Precision Therapy Phase III

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically confirmed hormone receptor-positive (ER and/or PR e10% by immunohistochemistry) and HER2-negative breast cancer
  • Confirmed SNF2, SNF3, or SNF4 subtype by molecular pathology
  • Clinical tumor stage cT1c-T2 with cN1-N2, or cT3-T4 with cN0-N2
  • Agreement to undergo breast cancer surgery if criteria met after neoadjuvant therapy
  • Adequate organ function including hemoglobin 90 g/L, neutrophils 1.5x10^9/L, platelets 75x10^9/L, liver enzymes and bilirubin within defined limits, serum creatinine and creatinine clearance >50 mL/min
  • Baseline left ventricular ejection fraction 55% by echocardiography or MUGA scan
  • Negative serum pregnancy test for women who could become pregnant
  • Use of medically approved contraception during treatment and for at least 3 months after last study drug dose
  • Voluntary informed consent with good compliance and willingness to follow-up
Not Eligible

You will not qualify if you...

  • 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 or prior excisional biopsy/radiotherapy of primary tumor or axillary nodes (except diagnostic biopsy or surgery for benign tumors)
  • Other malignancies within past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer
  • Participation in another investigational drug study within 4 weeks prior to randomization
  • Peripheral neuropathy grade 2 or higher
  • Severe cardiovascular or cerebrovascular disease within 6 months before randomization including congestive heart failure, unstable angina, severe arrhythmias, significant valvular disease, uncontrolled hypertension, recent myocardial infarction or stroke
  • Severe uncontrolled systemic diseases that may interfere with treatment
  • Major surgery within 4 weeks before randomization without full recovery or planned major surgery during treatment
  • Use of systemic corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks before first study drug dose (except certain topical or low-dose steroids)
  • Recent administration of anti-cancer or live vaccines within 4 weeks before first study drug dose
  • Active autoimmune disease or history of autoimmune disorders except specified stable conditions
  • Immunodeficiency or history of organ or bone marrow transplantation
  • History of interstitial lung disease or non-infectious pneumonitis
  • Active liver disease including hepatitis B or C or autoimmune hepatitis
  • Pregnancy or breastfeeding
  • Known hypersensitivity to study drugs or severe allergic reactions to monoclonal antibodies
  • History of substance abuse or addiction
  • Uncontrolled psychiatric or neurological disorders or poor compliance
  • Any other condition that increases study risk or interferes with treatment as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Z

Zhimin Shao, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Neoadjuvant SNF Precision Therapy Phase III | DecenTrialz