Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.
- Conditions
- HER2 Positive Breast Cancer
- Interventions
- Registration Number
- NCT03735966
- Lead Sponsor
- Henan Cancer Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
- female patients, 18 years ≤ age ≤ 75 years.
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Life expectancy of more than 3 months
- Known hormone receptor status.
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- Signed the informed consent form prior to patient entry.
- metastatic disease (Stage IV) or inflammatory breast cancer.
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pyrotinib plus trastuzumab and docetaxel and carboplatin Pyrotinib plus trastuzumab and docetaxel and carboplatin Pyrotinib + trastuzumab + docetaxel+carboplatin
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR) through study completion, an average of 1 year Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated
- Secondary Outcome Measures
Name Time Method EFS Following surgery until Year 5 Event-free survival
DFS Following surgery until Year 5 Disease-free Survival
DDFS Following surgery until Year 5 Distance Disease-free Survival
ORR Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months Objective Response Rate
Trial Locations
- Locations (1)
Henan cancer hospital
🇨🇳Zhengzhou, Henan, China