Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy
Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xuran Zhao, Doctor
- Phone Number: 13661135602
- Email: 923791362@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
Time Frame: From enrollment to the completion of surgery
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC4456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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