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

NCT ID: NCT03735966

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2020-10-20

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.

Conditions

HER2 Positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pyrotinib plus trastuzumab and docetaxel and carboplatin

Pyrotinib + trastuzumab + docetaxel+carboplatin

Group Type: EXPERIMENTAL

Pyrotinib plus trastuzumab and docetaxel and carboplatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenzhen Liu

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Henan Cancer Hospital

Locations

Henan cancer hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HR-NeoBC-HN002

Identifier Type: -

Identifier Source: org_study_id