drugset / Trial / NCT00196859
Study in Elderly Patients With Early Breast Cancer (ICE)
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is done to determine the role of adjuvant chemotherapy with capecitabine in patients ≥ 65.
Timeline
- Start
- 2004-06
- Primary completion
- 2014-01
- Completion
- 2014-01
Publications
- Schmidt M, Nitz U, Reimer T, Schmatloch S, Graf H, Just M, Stickeler E, Untch M, Runnebaum I, Belau A, Huober J, Jackisch C, Hofmann M, Krocker J, Nekljudova V, Loibl S; GBG/AGO-B, NOGGO/WSG study groups. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE randomized clinical trial. Eur J Cancer. 2023 Nov;194:113324. doi: 10.1016/j.ejca.2023.113324. Epub 2023 Sep 7.
- Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Comparator | Ibandronate | Other / unclassified | 6 mg | Oral |
| Comparator | Ibandronate | Other / unclassified | 50 mg | Oral |