drugset / Trial / NCT00209092
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Phase 2
Completed
51 enrolled
Emory University
Georgia Center for Oncology Research & Education · collabSanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Timeline
- Start
- 2006-08
- Primary completion
- 2009-07
- Completion
- 2012-10
Publications
- Results Zelnak AB, Styblo TM, Rizzo M, Gabram SG, Wood WC, Harichand-Herdt S, Kim S, Liu Y, O'Regan RM; Georgia Center for Oncology Research and Education. Final results from phase II trial of neoadjuvant docetaxel and capecitabine given sequentially or concurrently for HER2-negative breast cancers. Clin Breast Cancer. 2013 Jun;13(3):173-9. doi: 10.1016/j.clbc.2012.12.004. Epub 2013 Jan 16.
- 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 |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |