drugset / Trial / NCT03123770
Efficacy and Safety of Neoadjuvant DC-T in Breast Cancer Patients
Phase 4
Unknown
384 enrolled
Zhejiang University
First Affiliated Hospital of Wenzhou Medical University · collabFirst Affiliated Hospital of Zhejiang University · collabFirst People's Hospital of Hangzhou · collabHangzhou Hospital of Traditional Chinese Medicine · collabJinhua Central Hospital · collabNingbo No. 1 Hospital · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabSir Run Run Shaw Hospital · collabWomen's Hospital School Of Medicine Zhejiang University · collabZhejiang Cancer Hospital · collabZhejiang Provincial Hospital of TCM · collabZhejiang Provincial People's Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.
Timeline
- Start
- 2016-12
- Primary completion
- 2021-12
- Completion
- 2021-12
Publications
- Background O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097.
- Background Vici P, Pizzuti L, Gamucci T, Sergi D, Conti F, Zampa G, Del Medico P, De Vita R, Pozzi M, Botti C, Di Filippo S, Tomao F, Sperduti I, Di Lauro L. Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients. J Cancer. 2014 Apr 25;5(6):398-405. doi: 10.7150/jca.9132. eCollection 2014.
- Background Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.
- Background Uriarte-Pinto M, Escolano-Pueyo A, Gimeno-Ballester V, Pascual-Martinez O, Abad-Sazatornil MR, Agustin-Ferrandez MJ. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer. Int J Clin Pharm. 2016 Apr;38(2):446-53. doi: 10.1007/s11096-016-0278-5. Epub 2016 Mar 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | — | — |
| Comparator | Epirubicin | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |