Neoadjuvant SNF Precision Therapy Phase III

NCT ID: NCT06913777

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2027-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

chemotherapy (wP-EC）

Group Type: ACTIVE_COMPARATOR

Chemotherapy (wP-EC)

Intervention Type: DRUG

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

Precision group

chemotherapy + target therapy

Group Type: EXPERIMENTAL

Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib

Intervention Type: 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.

Chemotherapy (wP-EC)

Intervention Type: DRUG

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

Interventions

Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib

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.

Intervention Type: DRUG

Chemotherapy (wP-EC)

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Director of General Surgery of Fudan Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhimin Shao, MD, PhD

Role: CONTACT

zhi_ming_shao@163.com

+86-021-64175590

Facility Contacts

Zhi-Ming Shao

Role: primary

zhi_ming_shao@163.com

Other Identifiers

SCHBCC-N090

Identifier Type: -

Identifier Source: org_study_id