Status:
RECRUITING
Neoadjuvant SNF Precision Therapy Phase III
Lead Sponsor:
Fudan University
Conditions:
Neoadjuvant Therapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
- Exclusion Criteria:
- 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.
- Any severe uncontrolled systemic disease that may interfere with the treatment plan, including significant cardiovascular, pulmonary, or metabolic disorders.
- Major surgery within 4 weeks prior to randomization without full recovery, or anticipated need for major surgery during the study treatment.
- Systemic corticosteroid use (\>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to the first dose of study drug (except for prophylactic anti-allergy or antiemetic purposes).
- \* Inhaled/topical steroids or physiologic steroid replacement doses (≤10 mg/day prednisone equivalent) are permitted in the absence of active autoimmune disease.
- Administration of anti-cancer vaccines or live vaccines within 4 weeks prior to the first dose of study drug.
- Active autoimmune disease or history of autoimmune disorders (e.g., interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyper/hypothyroidism), EXCEPT:
- Vitiligo,
- Childhood asthma/allergies resolved without intervention in adulthood,
- Stable hypothyroidism on hormone replacement,
- Type 1 diabetes on stable insulin therapy.
- Exclusion: Asthma requiring bronchodilators.
- Immunodeficiency (e.g., HIV-positive, congenital/acquired immune deficiency) or history of organ/allogeneic bone marrow transplantation.
- History of interstitial lung disease (except radiation pneumonitis without steroid treatment) or non-infectious pneumonitis.
- Active liver disease, including:
- Hepatitis B (HBsAg-positive with HBV-DNA ≥1000 IU/mL),
- Hepatitis C (HCV-Ab-positive with detectable HCV-RNA), or
- Autoimmune hepatitis.
- Pregnancy or lactation.
- Known hypersensitivity to the study drug(s), its excipients, or severe allergic reactions to monoclonal antibodies.
- History of substance abuse, alcoholism, or drug addiction.
- Uncontrolled psychiatric/neurological disorders (e.g., epilepsy, dementia) or poor compliance.
- Any other condition that may increase study risk, interfere with treatment/outcomes, or render the patient unsuitable for participation per investigator's judgment.
Exclusion
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2027
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT06913777
Start Date
April 8 2025
End Date
April 15 2027
Last Update
June 6 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032