A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER
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.
| Condition(s) | Breast Cancer, Neoadjuvant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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% * Normal function of major organs: 1. The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L 2. Biochemical examination should meet the following standards: TBIL≤ the upper limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); 3. Cardiac color ultrasound and |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Locations | Wuhan, Hubei, China; Wuhan, Hubei, China |
| Start date | 2023-05-11 |
| NCT ID | NCT06000917 |
| Official listing | https://clinicaltrials.gov/study/NCT06000917 |