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

• Status: Unknown status
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shandong University
• 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）

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

5. Known hormone receptor status.

6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO

7. Signed informed consent form (ICF)

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.