Study in Elderly Patients With Early Breast Cancer (ICE)

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

Outcome

Missed primary endpoint

paper At a median follow-up of 61.3 months, 5-year iDFS was 78.8% for Cap+Ib versus 75.0% for Ib alone (p = 0.80). PMID 37797387 ↗

paper The adjuvant combination of Cap+Ib did not show significantly better iDFS than Ib alone in node-positive/high-risk node-negative older BC patients PMID 37797387 ↗

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

Indications