Neoadjuvant SNF Precision Therapy Phase III

Phase 3

Not yet recruiting

• Conditions: Neoadjuvant Therapy
• Interventions: Drug: Chemotherapy (wP-EC)

• Registration Number: NCT06913777
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-30
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Study Start: 2025-04-15
• Primary Completion: 2026-10-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 404

Inclusion Criteria

Not provided

Exclusion Criteria

1. Stage IV (metastatic) breast cancer.

2. History of invasive breast cancer.

3. History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).

4. 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).

5. Other malignancies within the past 5 years (except cured cervical carcinoma in situ or non-melanoma skin cancer).

6. Participation in any other investigational drug study within 4 weeks prior to randomization.

7. Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0).

8. 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.

9. Any severe uncontrolled systemic disease that may interfere with the treatment plan, including significant cardiovascular, pulmonary, or metabolic disorders.

10. Major surgery within 4 weeks prior to randomization without full recovery, or anticipated need for major surgery during the study treatment.

11. 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.

12. Administration of anti-cancer vaccines or live vaccines within 4 weeks prior to the first dose of study drug.

13. 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.

14. Immunodeficiency (e.g., HIV-positive, congenital/acquired immune deficiency) or history of organ/allogeneic bone marrow transplantation.

15. History of interstitial lung disease (except radiation pneumonitis without steroid treatment) or non-infectious pneumonitis.

16. 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.

17. Pregnancy or lactation.

18. Known hypersensitivity to the study drug(s), its excipients, or severe allergic reactions to monoclonal antibodies.

19. History of substance abuse, alcoholism, or drug addiction.

20. Uncontrolled psychiatric/neurological disorders (e.g., epilepsy, dementia) or poor compliance.

21. Any other condition that may increase study risk, interfere with treatment/outcomes, or render the patient unsuitable for participation per investigator's judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Chemotherapy (wP-EC)	chemotherapy (wP-EC）
Precision group	Chemotherapy (wP-EC)	chemotherapy + target therapy

Primary Outcome Measures

Name	Time	Method
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)	Up to approximately 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Approximately 5 years	OS is defined as the time from randomisation until the date of death due to any cause.
Objective Response Rate (ORR)	Approximately 1 year	ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Event-free survival (EFS) rate at 12, 24, 36-month	Up to approximately 3 years	EFS is defined as time from date of randomisation until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Invasive disease-free survival (IDFS) rate at 12, 24, 36-month	Up to approximately 3 years	IDFS is defined as time from surgery until invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).	Up to approximately 1.5 years	Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center,; 🇨🇳 Shanghai, Shanghai, China