RecruitingPhase 2NCT06000917

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

A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab,Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer


Sponsor

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

Enrollment

62 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination drug regimen called TCHpy — pyrotinib, trastuzumab, carboplatin, and paclitaxel — as a pre-surgery treatment (neoadjuvant therapy) for women with HER2-positive breast cancer that also has estrogen receptor (ER) activity. **You may be eligible if...** - You are a female patient between 18 and 75 years old with no prior treatment for this cancer - Your breast cancer has been confirmed as HER2-positive by biopsy - Your tumor has an estrogen receptor (ER) positivity of at least 10% - Your tumor is at early or locally advanced stage with a primary tumor of at least 2 cm or lymph node involvement - Your blood counts, liver function, kidney function, and heart function meet the required minimums **You may NOT be eligible if...** - You have been previously treated for breast cancer - Your heart function (ejection fraction) is below the required threshold - Your organ function tests (blood, liver, kidney) are significantly abnormal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpyrotinib,Trastuzumab,carboplatin,Albumin paclitaxel

Pyrotinib tablets: 320mg qd, oral administration after breakfast, 21 days for 1 cycle, continuous administration of 6 cycles. Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles. Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given. Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration


Locations(2)

WuhanHU

Wuhan, Hubei, China

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

Wuhan, Hubei, China

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NCT06000917


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