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Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

First Safety Data from a Randomized Phase III (CIBOMA/2004-01/GEICAM 2003-11) Trial Assessing Adjuvant Capecitabine Maintenance Therapy After Standard Chemotherapy for Triple-Negative Early Breast Cancer. Lluch A et al. Proc SABCS 2010;Abstract P5-10-15. Study Design. Accrual: 816 (Open).

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Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

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  1. First Safety Data from a Randomized Phase III (CIBOMA/2004-01/GEICAM 2003-11) Trial Assessing Adjuvant Capecitabine Maintenance Therapy After Standard Chemotherapy for Triple-Negative Early Breast Cancer Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

  2. Study Design • Accrual: 816 (Open) Safety data reported for first 400 patients (pts) Capecitabine 1,000 mg/m2 BID d1-14 q3wks x 8 R Observation Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

  3. Treatment-RelatedGrade 3/4 Adverse Events* * Grade 3/4 events occurring in ≥2 patients in either treatment arm; † Grade 3 only Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

  4. Proportion of Cycles with Treatment Discontinuation Due to Toxicity Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

  5. Selected Reasons for Discontinuation Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

  6. Author Conclusions • The safety profile of adjuvant capecitabine as maintenance therapy is consistent with its known toxicity profile. • More than 75% of patients are able to complete their treatment as planned, with approximately 15% of patients discontinuing due to toxicity or patient withdrawal. • Ongoing recruitment with an accrual of 876 patients is planned. Lluch A et al. Proc SABCS 2010;Abstract P5-10-15.

  7. Investigator Commentary: Maintenance Capecitabine After Adjuvant Chemotherapy for Triple-Negative Breast Cancer The CIBOMA/GEICAM investigators demonstrated that administering maintenance capecitabine after standard adjuvant chemotherapy for patients with triple-negative early breast cancer was not associated with excessive capecitabine-associated side effects, and hand-foot syndrome and diarrhea were the most common adverse events. This was a preliminary report, and efficacy data are not yet available. Interview with William J Gradishar, MD, January 4, 2011 The Swiss have been investigating metronomic cyclophosphamide and methotrexate as maintenance therapy in the adjuvant setting. We were interested in joining the Swiss study, but we were unhappy about approaching patients to undergo a year of maintenance therapy. I have used capecitabine a lot as a single agent for metastatic disease, and it may not be a “slam dunk” to administer it as maintenance therapy, even though it’s orally administered. Patients must be carefully watched because they “soldier on” and do not always report symptoms. Using maintenance capecitabine will require careful management and watching the dose closely. However, if this approach turns out to be positive, then we will all be using maintenance therapy. Interview with Kathleen I Pritchard, MD, December 30, 2010

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