Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy
Recruiting
Phase 3
Interventional Study
Breast Cancer
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.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 280 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female patients aged 18 to 75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Histologically confirmed unilateral primary invasive breast cancer, staged as at least cT2 or cN1 (i.e., AJCC 8th edition stage II-III), and M0.
* Pathologically co…
Contacts