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NCT06671262: NEOTRIO-HR
Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer
Phase 2 trial testing SBRT in Breast Adenocarcinoma in 74 participants. Currently enrolling.
1 November 2026
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 26 December 2024 |
| Primary completion | 1 November 2026 |
| Estimated completion | 1 November 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- SBRT — full drug profile →
- Immuno-chemotherapy — full drug profile →
Conditions studied
- Breast Adenocarcinoma — all drugs for Breast Adenocarcinoma →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 18 to 85, female only, with Breast Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are: * Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？ * Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy? Participants will be randomly assigned to one of three treatment regimens: 1. Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy; 2. Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy; 3. Preoperative toripalimab combined with chemotherapy alone. Following the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment. The study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06671262
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other recruiting trials for Breast Adenocarcinoma
Currently open trials in the same condition.
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Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06671262 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 11 February 2025
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