A Study of Neoadjuvant TCHpy(Pyrotinib ,Trastuzumab,Carboplatin and Paclitaxel)for ER+/HER2+ Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.

Eligibility criteria

Qualifiers

Newly treated female patients aged ≥18 years and ≤75 years;

ECOG score 0~1;

Pathologically diagnosed as HER2-positive breast cancer patients with early or locally advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;

Hormone receptor status (ER and PgR) is known, where ER≥10%

Disqualifiers

Stage IV (metastatic) breast cancer;

Inflammatory breast cancer;

Previous antitumor therapy or radiation therapy for any malignancies, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;

Also receiving antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;

Trial design

Treatments tested in this trial

  • pyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel

Treatment groups

62 Participants
are divided into 1 treatment group

Locations

2
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology WuhanHubei, China
WuhanHU430000, WuhanHubei, China

Sponsors and collaborators

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor