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• W2335102791 abstract "Introduction: Zoledronic acid (ZOL) has been shown to reduce the risk of recurrence and residual tumor size in the adjuvant/neoadjuvant setting in patients with early/intermediate-stage breast cancer (BC). In addition, ZOL combined with neoadjuvant chemotherapy reduced numbers of disseminated-tumor cells in the bone marrow compared with chemotherapy alone. However, the activity of ZOL on disseminated- or circulating-tumor cells (CTCs) in patients with metastatic breast cancer (MBC) is not well defined. Cristofanilli M, et al ( J Clin Oncol. 2005; 23: 1420–30) reported that CTCs in MBC are an independent predictor of overall survival (OS) and progressionfree survival (PFS). Accordingly, this study is evaluating the potential anticancer benefit of adding ZOL to standard therapy in patients with newly diagnosed MBC as assessed by the change in CTC count from baseline to 3–5 weeks. Methods: Eligible patients had HER2−negative MBC, newly diagnosed or at first relapse after adjuvant therapy with or without bone metastases. In this open-label 3-arm study, patients without bone metastases were randomized to standard therapy + ZOL every 3–4 weeks for the first 6 months (Arm A) or standard therapy + ZOL during month 6–12 after standard therapy initiation (Arm B). All patients with bone metastases received ZOL every 3–4 weeks (Arm C). The primary endpoint is PFS. Secondary endpoints include the proportion of patients with CTCs ≥5 or Results: In Z-ACT1, 29 previously untreated MBC patients with bone metastases were enrolled in Arm C, all of whom had ≥1 CTC at study entry (range, 1–117). 53% received hormonal therapy alone, 42% chemotherapy alone, and 5% received various combinations. In patients receiving standard therapy + ZOL, the percentage of patients with CTC ≥5 decreased from 55% to 25% at 3–5 weeks. At baseline, the median uNTX level was 46.5 (n = 10) in patients with Conclusions: This preliminary analysis suggests that the addition of ZOL to standard therapy in women with bone metastases from MBC results in a further decrease in CTC numbers at 3–5 weeks after initiation of therapy. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-18-01." @default.
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• W2335102791 date "2011-12-15" @default.
• W2335102791 modified "2023-09-26" @default.
• W2335102791 title "P1-18-01: Z-ACT1: Zometa Combined with Standard Therapy in Patients with Metastatic Breast Cancer Further Decreases the Proportion of Patients with CTC Counts of 5 or above." @default.
• W2335102791 doi "https://doi.org/10.1158/0008-5472.sabcs11-p1-18-01" @default.
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