drugset / Trial / NCT00563953
Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.
Timeline
- Start
- 2007-09
- Primary completion
- 2011-02
- Completion
- 2016-08
Publications
- 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.
- Results Gil MJ, Bellet MC, Llombart, Ojeda B, Manso L, Mesia C, Morales S, García-Martinez H, Martínez N, Melé M, Fernández-Ortega A, Baselga J. Pegylated Liposomal Doxorubicin (PLD) as Primary Treatment in Estrogen Receptor (ER) and HER2 Poor Breast Cancer and Risk of Developing Cardiotoxicity or Elderly Patients (pt). Results from the Phase II CAPRICE Study. Cancer Research 71(24 Suppl.): 403s, 2011.(CTRC-AACR San Antonio Breast Cancer Symposium)
- Gil-Gil MJ, Bellet M, Bergamino M, Morales S, Barnadas A, Manso L, Saura C, Fernandez-Ortega A, Garcia-Martinez E, Martinez-Janez N, Mele M, Villagrasa P, Celiz P, Perez Martin X, Ciruelos E, Pernas S. Long-Term Cardiac Safety and Survival Outcomes of Neoadjuvant Pegylated Liposomal Doxorubicin in Elderly Patients or Prone to Cardiotoxicity and Triple Negative Breast Cancer. Final Results of the Multicentre Phase II CAPRICE Study. Front Oncol. 2021 Jul 9;11:645026. doi: 10.3389/fonc.2021.645026. eCollection 2021.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 35 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |