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Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer

NCT04872985 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-06

No results posted yet for this study

Summary

This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for women with hormone receptor positive HER2-negative stage II to III breast cancer. Patients randomized to the study arm/control arm will receive standard neoadjuvant chemotherapy in combination with pyrotinib/placebo, respectively. The primary endpoint of the study is the residual cancer burden 0/I (RCB 0/I) and total pathological complete response (tpCR) rate. Secondary endpoints include the breast pCR (bpCR) rate, objective response rate(ORR), event-free survival (EFS), overall survival (OS), rate of change in the Ki-67 proliferation index, correlations between potential biomarkers and treatment efficacy, and toxicity.

Conditions

Interventions

DRUG

Pyrotinib

400 mg orally once per day. Pyrotinib starts with a dose of 240 mg once daily for one week, followed by 320 mg once daily for the next week, before transitioning to 400 mg once daily as maintenance therapy.

DRUG

Epirubicin

100 mg/m2,q3W\*4

DRUG

Doxorubicin Hydrochloride Liposome Injection

30mg/m2, q3w\*4

DRUG

Cyclophosphamide

600 mg/m2, q3w\*4

DRUG

Docetaxel

100 mg/m2, q3w\*4

DRUG

Nab paclitaxel

120mg/m2 qw\*12 or 260mg/m2 q3w\*4

DRUG

Placebo

400 mg orally once per day

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Erwei Song, MD.,Phd. · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2026-02-27
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872985 on ClinicalTrials.gov