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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 24 words
    • Collaborators expanded, about 24 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 120 to 318
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 1 of 4 entries
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06627712
Lead Sponsor West China Hospital
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Cancer Hospital and Institute
Conditions
(from sponsor)
TNBC - Triple-Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 318 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov