drugset / Trial / NCT04172259
ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC
Phase 2
Active not recruiting
156 enrolled
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Breast cancer is the most common malignant tumor in women. EC-TH is one of the standard chemotherapy regimens for HER-2 positive early breast cancer(EBC). Earlier use of trastuzumab may improve DFS rate. In this study, the investigators want to find out whether ACH-TH regimen compared with the EC-TH regimen in HER2+ EBC could improve the pCR rate in neoadjuvant chemotherapy. We update protocol in Sep 2020, because Pertuzumab is approveled by Chinese goverment and coverd by national insurance, dual target therapy with Trastuzumab and Pertuzumab is the standard therapy for neoadjuvant therapy of HER2-positive EBC patients.
Timeline
- Start
- 2019-01-10
- Primary completion
- 2023-09-30
- Completion
- 2026-09-30
Publications
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- Background Martin M, Sanchez-Rovira P, Munoz M, Baena-Canada JM, Mel JR, Margeli M, Ramos M, Martinez E, Garcia-Saenz JA, Casado A, Jaen AM, Gonzalez-Farre X, Escudero MJ, Rodriguez-Martin C, Carrasco E; GEICAM. Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol. 2011 Dec;22(12):2591-2596. doi: 10.1093/annonc/mdr024. Epub 2011 Mar 17.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin liposome | Unknown | 35 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Docetaxel | Small molecule | 75 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 260 mg/m2 | — |
| Background | Pertuzumab | Monoclonal antibody | 420 mg | — |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |