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Toripalimab / Stereotactic Body Radiation Therapy (SBRT) / Surgery · Phase 2 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial (NCT06914440) evaluating neoadjuvant SBRT followed by nab-paclitaxel plus toripalimab in HR+/HER2− breast cancer. No results have been posted in this registry record. The study is currently recruiting and is designed to measure total pathologic complete response (tpCR) rate as the primary endpoint.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer; Female; age from 18 Years; to 75 Years. Intervention: Treatment. n = 27. 2 sites: China.
This is a planned Phase 2 trial (NCT06914440) evaluating neoadjuvant SBRT followed by nab-paclitaxel plus toripalimab in HR+/HER2− breast cancer. No results have been posted in this registry record. The study is currently recruiting and is designed to measure total pathologic complete response (tpCR) rate as the primary endpoint.
This is a registry record with no results posted; no efficacy or safety data are reported.
Results of this trial are not yet available. Once published, efficacy and safety data for this de-escalated chemotherapy approach combined with immunotherapy and radiotherapy in high-risk HR+/HER2− breast cancer will inform neoadjuvant strategy selection in this population.
This is a Phase 2 interventional trial registration with no posted results; it describes a planned study of neoadjuvant SBRT plus chemotherapy and immunotherapy in HR+/HER2− breast cancer, currently recruiting 27 participants.
As stated by the source record.
Quoted from the source exactly as published.
Results of this trial are not yet available. Once published, efficacy and safety data for this de-escalated chemotherapy approach combined with immunotherapy and radiotherapy in high-risk HR+/HER2− breast cancer will inform neoadjuvant strategy selection in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06914440). This is a study registration, not published results. Lead sponsor: Xijing Hospital. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 27 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: RADIATION: Stereotactic Body Radiation Therapy (SBRT); DRUG: Toripalimab; DRUG: Neoadjuvant Chemotherapy; PROCEDURE: Surgery; DRUG: Adjuvant Chemotherapy; RADIATION: Adjuvant Radiotherapy; DRUG: Endocrine therapy. Primary outcome measures: Total pathologic complete response (tpCR) rate according to RCB system , At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.. Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) followed by nab-paclitaxel combined with toripalimab in patients with previously untreated HR+/HER2-negative breast cancer. Eligible patients include those with stage IIB-IIIC disease (cT3N0, cT2-4N1-3 or cT1N2-3) or stage IIA disease (cT2N0 or cT1N1) with at least two of the following high-risk factors: histologic grade 3, Ki-67 ≥50% or premenopausal with age \<50 years. A total of 27 enrolled patients will be assigned to receive the combination therapy. The primary question it aims to answer is whether this combination of radiotherapy, de-escalated chemotherapy, and immunotherapy can improve the total pathologic complete response (tpCR) rate (defined as ypT0/Tis ypN0).
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