RecruitingPhase 3NCT06627712

SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC

Stereotactic Body Radiotherapy (SBRT) Combined With PD-1 Inhibitor and Chemotherapy in Early-stage Treatment-naive Triple-negative Breast Cancer Patients: A Multicenter Phase III Clinical Study


Sponsor

West China Hospital

Enrollment

318 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes. Studies like Keynote522 and IMpassion031 have shown that combining chemotherapy with immunotherapy yields a pCR rate of 64.8% in early-stage high-risk TNBC patients, suggesting that such combinations can offer substantial benefits. However, the low immunogenicity of breast cancer and the lack of clear predictive molecular markers for effective immunotherapy result in suboptimal pCR and objective response rates for this group. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of stereotactic radiotherapy combined with PD-1 inhibitors and chemotherapy in the neoadjuvant treatment of TNBC.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial tests adding focused radiation therapy (SBRT — stereotactic body radiation therapy) to standard chemotherapy plus immunotherapy (anti-PD1) for patients with early-stage triple-negative breast cancer (TNBC) before surgery. TNBC is an aggressive type of breast cancer that lacks estrogen, progesterone, and HER2 receptors. **You may be eligible if...** - You have been diagnosed with triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) confirmed by biopsy - Your cancer is early stage with limited lymph node involvement (cT1N1-2 or cT2N0-2) - You are in good general health (ECOG 0–1) - Your blood counts and organ function are within normal limits **You may NOT be eligible if...** - Your cancer is HER2-positive or hormone receptor-positive - You have distant metastases - You have had previous treatment for this cancer - You have significant abnormalities in blood counts, liver, or kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSBRT+PD-1 Inhibitor + Chemotherapy

Radiotherapy: 24Gy/3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle; Carboplatin AUC=5, IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks

DRUGPD-1 Inhibitor + Chemotherapy

Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle; Carboplatin AUC=5, IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks


Locations(1)

West China Hospital, Sichuan University

Sichuan, Chengdu, China

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NCT06627712


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