Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer

Summary

The study is designed to assess the treatment outcomes following treatment with letrozole plus metronomic capecitabine in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their recurrent /metastatic disease.

Timeline

Start

2023-08-30

Primary completion

2024-08-01

Completion

2025-05-31

Publications

• Background Shankar A, Rath G, Roy S, Malik A, Bhandari R, Kishor K, Barnwal K, Upadyaya S, Srivastava V, Singh R. Level of awareness of cervical and breast cancer risk factors and safe practices among college teachers of different states in india: do awareness programmes have an impact on adoption of safe practices? Asian Pac J Cancer Prev. 2015;16(3):927-32. doi: 10.7314/apjcp.2015.16.3.927.
• Background Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
• Background Winkfield KM, Harris JR. Effective local therapy and long-term survival in breast cancer. Oncology (Williston Park). 2009 Jul;23(8):669-75.
• Background Schwartzberg LS, Wang G, Somer BG, Blakely LJ, Wheeler BM, Walker MS, Stepanski EJ, Houts AC. Phase II trial of fulvestrant with metronomic capecitabine for postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Breast Cancer. 2014 Feb;14(1):13-9. doi: 10.1016/j.clbc.2013.09.003. Epub 2013 Sep 27.
• Background Van Cutsem E, Twelves C, Cassidy J, Allman D, Bajetta E, Boyer M, Bugat R, Findlay M, Frings S, Jahn M, McKendrick J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schmiegel WH, Seitz JF, Thompson P, Vieitez JM, Weitzel C, Harper P; Xeloda Colorectal Cancer Study Group. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol. 2001 Nov 1;19(21):4097-106. doi: 10.1200/JCO.2001.19.21.4097.
• Background Seidman AD, O'Shaughnessy J, Misset JL. Single-agent capecitabine: a reference treatment for taxane-pretreated metastatic breast cancer? Oncologist. 2002;7 Suppl 6:20-8. doi: 10.1634/theoncologist.7-suppl_6-20.
• Background Walko CM, Lindley C. Capecitabine: a review. Clin Ther. 2005 Jan;27(1):23-44. doi: 10.1016/j.clinthera.2005.01.005.
• Background Munzone E, Di Pietro A, Goldhirsch A, Minchella I, Verri E, Cossu Rocca M, Marenghi C, Curigliano G, Radice D, Adamoli L, Nole F. Metronomic administration of pegylated liposomal-doxorubicin in extensively pre-treated metastatic breast cancer patients: a mono-institutional case-series report. Breast. 2010 Feb;19(1):33-7. doi: 10.1016/j.breast.2009.10.003. Epub 2009 Nov 1.
• Background Mehta RS. Dose-dense and/or metronomic schedules of specific chemotherapies consolidate the chemosensitivity of triple-negative breast cancer: a step toward reversing triple-negative paradox. J Clin Oncol. 2008 Jul 1;26(19):3286-8; author reply 3288. doi: 10.1200/JCO.2008.17.1116. No abstract available.
• Background Emmenegger U, Kerbel RS. Five years of clinical experience with metronomic chemotherapy: achievements and perspectives. Onkologie. 2007 Dec;30(12):606-8. doi: 10.1159/000111479. Epub 2007 Nov 30. No abstract available.
• Background Bottini A, Generali D, Brizzi MP, Fox SB, Bersiga A, Bonardi S, Allevi G, Aguggini S, Bodini G, Milani M, Dionisio R, Bernardi C, Montruccoli A, Bruzzi P, Harris AL, Dogliotti L, Berruti A. Randomized phase II trial of letrozole and letrozole plus low-dose metronomic oral cyclophosphamide as primary systemic treatment in elderly breast cancer patients. J Clin Oncol. 2006 Aug 1;24(22):3623-8. doi: 10.1200/JCO.2005.04.5773.
• Background Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

Drugs

Indications