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