Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer
NCT04917900 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2022-10-10
Summary
This study aimed to evaluate the Pyrotinib in combination with albumin-bound paclitaxel and trastuzumab to neoadjuvant therapy efficacy and safety of Her2-positive early or locally advanced breast cancer
Conditions
Interventions
- DRUG
-
Pyrotinib combined with albumin-bound paclitaxel and trastuzumab
Pyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Principal Investigators
-
Ting Luo, post-doctor · West China Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-01
- Primary Completion
- 2023-08-30
- Completion
- 2023-12-31
Countries
- China
Study Locations
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