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

NCT04290793 | Active Not Recruiting Phase 2

• 1 other identifier: HRHB-CB001
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate(ORR)

  2 years

• Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause

  3 years

• bpCR

  immediately after surgery

• Adverse Events rate

  1-year

Study Arms (1)

Experimental group

ACTIVE COMPARATOR

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

Drug: Pyrotinib; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Taxanes; Biological: Trastuzumab

Interventions

Pyrotinib DRUG

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

Experimental group

Epirubicin DRUG

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

Experimental group

Cyclophosphamide DRUG

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

Experimental group

Taxanes DRUG

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

Experimental group

Trastuzumab BIOLOGICAL

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer patients at the age of \>= 18 years and \<= 70 years who received first treatment；
• 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)；
• 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；
• The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
• 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%;
• 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;
• A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.

You may not qualify if:

• Known history of hypersensitivity to pyrotinib or any of it components;
• 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);
• Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
• Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
• Patients with severe heart disease or discomfort who cannot be treated;
• The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
• Pregnant or lactating women;
• Less than 4 weeks from the last clinical trial;
• Patients participating in other clinical trials at the same time
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Epirubicin; Cyclophosphamide; Taxoids; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: March 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (1)