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Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: 2 to 8
    • Study description expanded, about 5 words
    v5
  2. Primary completion date: Apr 2026 to Dec 2026v4
  3. Start date changed from estimate of Jun 2025 to Jun 5, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2025 to Jun 2025
    • Study sites: 1 to 2
    • Eligibility criteria shortened, about 3 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Xijing Hospital
179 trials monitored
See 8 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
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).
Trial Details
NCT Number NCT06914440
Lead Sponsor Xijing Hospital
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov