Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Pyrotinib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Taxanes; Biological: Trastuzumab

• Registration Number: NCT04290793
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief Summary

This is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study Start: 2020-03-01
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02
• Primary Completion: 2022-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

1. Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment；
2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.

Exclusion Criteria

1. Known history of hypersensitivity to pyrotinib or any of it components;
2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
5. Patients with severe heart disease or discomfort who cannot be treated;
6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
7. Pregnant or lactating women;
8. Less than 4 weeks from the last clinical trial;
9. Patients participating in other clinical trials at the same time
10. The researchers think inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Epirubicin	Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Experimental group	Trastuzumab	Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Control group	Trastuzumab	Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Experimental group	Taxanes	Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Control group	Taxanes	Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Experimental group	Pyrotinib	Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Experimental group	Cyclophosphamide	Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Control group	Epirubicin	Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab
Control group	Cyclophosphamide	Patients will only receive Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response rate(pCR)	within 3 weeks after surgery	pathological complete response

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	2 years	Baseline to measured stable disease
Event Free Survival(EFS)	3 years	Baseline to the occurrence of any event
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause	3 years	Baseline to measured date of recurrence or death from any cause
Overall survival (OS)	5 years	Baseline to measured date of death from any cause