Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Breast Cancer

• Status: Recruiting
• Trial end date: 2024-11-20
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Carboplatin; Docetaxel; Trastuzumab

Criteria

Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 75 years.

2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.

3. Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter

4. HER2 positive (HER2+++ by IHC or FISH+)

5. Life expectancy of more than 3 months

6. Known hormone receptor status.

7. 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.

8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer.

2. 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.

3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);

4. Unable or unwilling to swallow tablets.