Actively Recruiting
A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2023-08-21
62
Participants Needed
2
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG performance status of 0 or 1
- Pathologically confirmed HER2-positive breast cancer with early or locally advanced stage, tumor size 2 cm or larger or lymph node positive
- Known hormone receptor status with estrogen receptor (ER) 10% or higher
- Normal major organ function including blood counts, liver and kidney tests, cardiac function (LVEF 55% or higher), and QTcF less than 470 ms
- Women not menopausal or surgically sterilized must agree to use effective contraception during treatment and for at least 7 months after last dose
- Willing to voluntarily participate and sign informed consent
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Inflammatory breast cancer
- Previous antitumor or radiation therapy for any malignancy except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
- Current participation in other antitumor clinical trials including endocrine, bisphosphonate, or immunotherapy
- Major surgery unrelated to breast cancer within 4 weeks prior to enrollment or not fully recovered
- Serious heart disease including heart failure, systolic dysfunction (LVEF <50%), or high-risk uncontrolled arrhythmias
- Inability to swallow or absorb oral medication
- Allergy to study drugs
- History of immunodeficiency or organ transplantation
- Pregnant or nursing women, or unwillingness to use effective contraception during and 7 months after study
- Serious other medical conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
WuhanHU
Wuhan, Hubei, China, 430000
Actively Recruiting
2
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
Y
Yao Jing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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