Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)
Recruiting
Phase 2
Interventional Study
HER2-positive Breast Cancer
Neoadjuvant Therapy
Pyrotinib
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 – 75
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 33 (estimated)
- Sponsor
- First Affiliated Hospital of Zhejiang University · Other
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About This Trial
This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR)and clinical complete response(cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS),…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1\. Female patients aged 18-75 years old; 2. ECOG score is 0-1 points; 3. Histologically confirmed invasive cancer meets the following standards:
* T1N1-3M0 or T2-4N0M0
* All patients were pathohistologically confirmed as HER2+ breast cancer. HER2 positivity was determined loca…