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

The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negati

Trial Details

NCT ID

NCT06914440

Phase

PHASE2

Sponsor

Xijing Hospital

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

Stereotactic Body Radiation Therapy (SBRT)
Toripalimab
Neoadjuvant Chemotherapy
Surgery
Adjuvant Chemotherapy
Adjuvant Radiotherapy

Locations (sample)

Xi'an, Shannxi Province, China|34.25833,108.92861
Xi'an, Shannxi, China|34.25833,108.92861

Key Eligibility Criteria

Female patients aged ≥18 and ≤75 years at the time of signing informed consent.
ECOG PS status of 0-1.
Breast cancer assessed as non-metastatic (M0), meeting all of the following:
Clinical stage: Stage IIB, IIIA, IIIB, or IIIC

For full eligibility, visit ClinicalTrials.gov.

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