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

NCT ID: NCT04290793

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2026-12-10

Brief Summary

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

Conditions

Breast Cancer

Study Design

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

Study Groups

Experimental group

Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib

Group Type: ACTIVE_COMPARATOR

Pyrotinib

Intervention Type: DRUG

400mg administered as continuous oral once daily from the first day of the study

Epirubicin

Intervention Type: DRUG

90mg/m\^2 d1 iv Q2W for 4 cycles

Cyclophosphamide

Intervention Type: DRUG

600 mg/m\^2 d1 iv Q2W for 4 cycles

Taxanes

Intervention Type: DRUG

Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )

Trastuzumab

Intervention Type: BIOLOGICAL

the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W

Interventions

Pyrotinib

400mg administered as continuous oral once daily from the first day of the study

Intervention Type: DRUG

Epirubicin

90mg/m\^2 d1 iv Q2W for 4 cycles

Intervention Type: DRUG

Cyclophosphamide

600 mg/m\^2 d1 iv Q2W for 4 cycles

Intervention Type: DRUG

Taxanes

Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )

Intervention Type: DRUG

Trastuzumab

the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Female breast cancer patients at the age of >= 18 years and <= 70 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Yunjiang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HRHB-CB001

Identifier Type: -

Identifier Source: org_study_id