Actively Recruiting
A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab, Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced 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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pyrotinib, trastuzumab, albumin paclitaxel, and carboplatin as neoadjuvant therapy for female patients with ER-positive and HER2-positive early or locally advanced breast cancer. This is a multicenter, single-arm, prospective, open-label clinical study aiming to assess the efficacy and safety of this treatment approach in this specific breast cancer population. The study is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology and is conducted in a Phase 2 setting. The treatment involves administering pyrotinib tablets orally at 320 mg daily for six continuous 21-day cycles. Trastuzumab is given intravenously with an initial dose of 8 mg/kg followed by 6 mg/kg from the second to sixth cycle every 21 days. Albumin paclitaxel is administered intravenously at 260 mg/m2 on the first day of each 21-day cycle for six cycles. Carboplatin dosing is based on kidney function using the Cockcroft formula, given at AUC 5 for six cycles every 21 days. The study follows a single-arm design, meaning all participants receive the combination treatment. Participants will undergo regular assessments including pathological response measurements, with the primary outcome being total pathological complete response at 2 years. Secondary outcomes include breast pathological complete response, overall response rate, and event-free survival evaluated over 2 to 5 years. Safety and cardiac function will be monitored closely through lab tests, echocardiography, ECGs, and other standard clinical evaluations. Participants are expected to be involved throughout the treatment and follow-up periods until study completion in May 2028.
CONDITIONS
Brief 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...
- Newly treated female patients aged 18 to 75 years
- ECOG performance status score of 0 to 1
- Pathologically confirmed HER2-positive breast cancer with early or locally advanced tumor stage
- Primary tumor diameter of 2 cm or larger, or positive lymph nodes
- Known hormone receptor status with estrogen receptor (ER) 10% or higher
- Normal blood counts: absolute neutrophil count at least 1.5 x 10^9/L, platelets at least 90 x 10^9/L, hemoglobin at least 90 g/L
- Normal biochemical liver and kidney function within specified limits
- Cardiac function with left ventricular ejection fraction (LVEF) 55% or higher
- Fridericia corrected QT interval (QTcF) less than 470 ms on ECG
- For non-menopausal or non-sterilized women: agreement to use effective contraception during treatment and for 7 months after last dose
- Willingness to join the study 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 malignancies (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma)
- Concurrent participation in other antitumor therapy clinical trials
- Major surgery unrelated to breast cancer within 4 weeks prior to enrollment or incomplete recovery from such surgery
- Serious heart conditions including history of heart failure or systolic dysfunction (LVEF below 50%), uncontrolled arrhythmias, or high-grade atrioventricular blocks
- Inability to swallow or intestinal obstruction affecting drug absorption
- Known allergy to study drug components
- History of immunodeficiency including HIV positive status or organ transplantation
- Women who are pregnant, nursing, or unwilling to use effective contraception throughout the trial and 7 months after last medication
- Presence of serious comorbidities or conditions interfering with planned treatment or deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive 6 cycles of combined chemotherapy and targeted therapy including pyrotinib, trastuzumab, carboplatin, and albumin-bound paclitaxel over approximately 18 weeks.
6 treatment cycles, each lasting 21 days
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here