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

NCT ID: NCT06691594

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2030-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

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.

Group Type: EXPERIMENTAL

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

Intervention Type: 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.

Interventions

neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

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.

Intervention Type: RADIATION

Other Intervention Names

radiotherapy combined with chemotherapy and immunotherapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

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

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shulian Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xuran Zhao, Doctor

Role: CONTACT

923791362@qq.com

13661135602

Other Identifiers

NCC4456

Identifier Type: -

Identifier Source: org_study_id