drugset / Trial / NCT04858529
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
RandomizedParallel-groupOpen-labelTreatment
Summary
The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.
Timeline
- Start
- 2021-04-30
- Primary completion
- 2024-04-30
- Completion
- 2025-04-30
Publications
- Gao HF, Ye GL, Lin Y, Huang Q, Dong J, Cao Y, Zhao YX, Chen QJ, Ma SH, Ouyang J, Ye JH, Yang HW, Zhang YQ, Zhang YC, Zhang GL, Li W, Zhang Y, Wu ZY, Lin YY, Zhu T, Zhang LL, Yang CQ, Yang M, Peng H, Chen B, Chen YT, Ji F, Cheng MY, Li JQ, Jiang Z, Wang K. Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial. J Clin Oncol. 2026 Jun 10;44(17):1587-1596. doi: 10.1200/JCO-25-02176. Epub 2026 Jan 23.
- Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Pertuzumab | Monoclonal antibody | — | — |
| Comparator | Trastuzumab | Monoclonal antibody | — | — |