Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer
Recruiting
Phase 2
Interventional Study
Breast Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 74 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* High-risk HR+/HER2-negative breast cancer is defined as ER≥1%, HER2-negative (\<2+ Her2 IHC or \<2.2 HER2/CEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS\>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). …
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