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Phase II Exploratory Study of Toripalimab Combined With SBRT in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy

NCT07410234 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-13

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab combined with radiochemotherapy as perioperative therapy in HER2-negative breast cancer patients insensitive to neoadjuvant chemotherapy.

This was a multicohort, single-center exploratory clinical study. Eligible patients were initially administered standard neoadjuvant chemotherapy (TAC or TE regimen). Efficacy assessment was performed after 2 cycles of neoadjuvant chemotherapy, and only those evaluated as stable disease (SD) were formally enrolled. Enrolled patients were stratified into the HR-positive group and the triple-negative breast cancer (TNBC) group, with each group further divided into 3 arms receiving the following treatments respectively:

* Cohort 1: Continued the original neoadjuvant chemotherapy for 4 cycles, followed by surgical treatment within 5 weeks for eligible patients.
* Cohort 2: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles, followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.
* Cohort 3: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles combined with concurrent stereotactic body radiation therapy (SBRT, 25Gy/5f), followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.

Conditions

Interventions

DRUG

Toripalimab

Preoperative: toripalimab, 240mg, IV, D1, Q3W. Preoperative toripalimab contains 4 cycles. Postoperative: Toripalimab 240mg, IV, D1, Q3W. . Postoperative Toripalimab following surgery within 5 weeks for 13 cycles.

RADIATION

SBRT

Local radiotherapy: Subjects received concurrent stereotactic body radiotherapy (SBRT，25 Gray in 5 fractions) for the primary lesion, within 5 weeks before the surgery.

DRUG

standard neoadjuvant chemotherapy regimens

standard neoadjuvant chemotherapy regimens for breast cancer: TAC, TE, etc. T: docetaxel, nab-paclitaxel or paclitaxel. Routine clinical dosage and administration shall be adopted. A: epirubicin, pirarubicin or doxorubicin. Routine clinical dosage and administration shall be adopted. C: cyclophosphamide 500 mg/m², IV. Q3W. Dose reduction and treatment delay are permitted; the maximum allowable delay is 3 weeks, calculated from the last administration date. Treatment shall be discontinued if this limit is exceeded. E: epirubicin. Routine clinical dosage and administration shall be adopted.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-21
Primary Completion
2028-02-21
Completion
2029-02-21

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410234 on ClinicalTrials.gov