Trials / Completed
CompletedNCT03735966
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer : a Single-arm,Ahead , Open-label Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Henan Cancer Hospital · Other Government
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Detailed description
Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyrotinib plus trastuzumab and docetaxel and carboplatin | pyrotinib: 320mg orally daily，6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ，AUC 6 iv 3-weekly for a total of 6 cycles |
Timeline
- Start date
- 2018-11-20
- Primary completion
- 2020-10-20
- Completion
- 2020-10-20
- First posted
- 2018-11-08
- Last updated
- 2022-12-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03735966. Inclusion in this directory is not an endorsement.