Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy

NCT06691594 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NCC4456
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.

Conditions

Breast Cancer Invasive

Keywords

preoperative radiothrapy; immunotherapy; triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

  pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment

  From enrollment to the completion of surgery

Study Arms (1)

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

EXPERIMENTAL

Eligible participants will receive neoadjuvant treatment consisting of: SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor). Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5). Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response. Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.

Radiation: neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

Interventions

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy RADIATION

Eligible participants will receive neoadjuvant treatment consisting of: SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor). Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5). Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response. Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.

Also known as: radiotherapy combined with chemotherapy and immunotherapy

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to enrollment
• Age ≥ 18 years
• ECOG PS score 0-1
• Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer
• Triple-negative breast cancer with PD-L1 CPS \< 10
• Hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L
• BUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN
• Serum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN
• Women of childbearing potential must be willing to use contraception during the study
• Negative serum or urine pregnancy test within 7 days prior to treatment

You may not qualify if:

• Occult breast cancer
• Bilateral breast cancer
• Breast tumor unsuitable for SBRT
• Unable to undergo MRI scanning
• History of other malignancies that may affect survival
• Active autoimmune disease or history of autoimmune disease
• Current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)
• Known allergy to any component of the investigational drugs
• Uncontrolled cardiac symptoms or diseases
• Active infection or unexplained fever \> 38.5°C during screening/before first dose
• Other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Central Study Contacts

Xuran Zhao, Doctor

CONTACT

13661135602; 923791362@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share