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

Pyrotinib Combined With Epirubicin and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab in Neoadjuvant Therapy of HER2-positive Early Breast Cancer: a Single-arm, Open-label, Multicenter Phase II Clinical Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Taxanes; Biological: Trastuzumab

• Study Type: Interventional
• Enrollment (Estimated): 113
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Experimental group; Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib

Drug: Pyrotinib; 400mg administered as continuous oral once daily from the first day of the study; Drug: Epirubicin; 90mg/m^2 d1 iv Q2W for 4 cycles; Drug: Cyclophosphamide; 600 mg/m^2 d1 iv Q2W for 4 cycles; Drug: Taxanes; Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles ); Biological: Trastuzumab; the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tpCR	It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.	immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate(ORR)	Baseline to measured stable disease	2 years
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause	Baseline to measured date of recurrence or death from any cause	3 years
bpCR	After neoadjuvant chemotherapy and surgery, breast was free of any invasive cancer	immediately after surgery
Adverse Events rate	Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0	1-year

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cyclodecanes; Diterpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Doxorubicin; Trastuzumab; Cyclophosphamide; Epirubicin; pyrotinib; Taxoids
• Other Study ID Numbers: HRHB-CB001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No