Recruiting

Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study

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What is being tested

Pyrotinib, trastuzumab, paclitaxel-albumin

Drug
Who is being recruted

Pathologic Complete Response+8

+ Breast Diseases

+ Breast Neoplasms

From 18 to 75 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorThe First Affiliated Hospital with Nanjing Medical University
Study ContactWenbin Zhou, Professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 29, 2022

Actual date on which the first participant was enrolled.

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

Official TitleNeoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study
NCT05659056
Principal SponsorThe First Affiliated Hospital with Nanjing Medical University
Study ContactWenbin Zhou, Professor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

65 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic Complete ResponseBreast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SitePathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesDisease ProgressionDisease Attributes

Criteria

8 inclusion criteria required to participate
female patients, 18 years ≤ age ≤ 75 years;

Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1

Histologically confirmed invasive breast cancer(early stage or locally advanced)

HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;

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5 exclusion criteria prevent from participating
metastatic disease (Stage IV) or inflammatory breast cancer

Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.

Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);

A history of allergy to the drugs in this study;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, ChinaOpen JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University in Google Maps
Recruiting
One Study Center