Neoadjuvant SNF Precision Therapy Phase III

Recruiting Phase 3 Interventional Study
Neoadjuvant Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
404 (estimated)
Sponsor
Fudan University · Other
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About This Trial

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.

Trial Locations
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Eligibility Criteria
Eligibility Criteria: 1. Female patients aged 18 to 70 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Histologically confirmed HR-positive/HER2-negative breast cancer (defined as: (1) ER-positive: ≥10% tumor cells positive by immunohistochemistry (IHC). (2) PR…
Contacts

Zhimin Shao, MD, PhD

+86-021-64175590

zhi_ming_shao@163.com

CONTACT