Table 2 Overview of Study Characteristics of Trials Included in the NMA
Trial | Brief Patient Description | RCT Design | Treatments | N Randomized | Objectives |
|---|---|---|---|---|---|
Study 301 NCT00337103 Kaufman 2015 [12] Twelves 2016 [13] Cortes 2015 [14] Pivot 2018 [15] | Women with MBC who had received prior anthracycline- and taxane-based therapy | Phase III Open-label | 1) ERI 2) CAP | 1102 | To compare ERI with CAP in patients with LABC or MBC. |
EMBRACE NCT00388726 Cortes 2011 [16] Twelves 2015 [17] Cardoso 2011 [18] | Women with heavily pre-treated (third line to fifth line) locally recurrent or MBC | Phase III Open-label | 1) ERI 2) TPC: 25% VIN, 19% GEM, 18% CAP, 15% taxanes, 10% anthracyclines, 10% other chemo, 4% hormonal therapy | 1102 | To compare OS of women with heavily pre-treated MBC receiving ERI or real-life treatment choices. |
Pallis, 2012 [19] NCT00431106 | Women with MBC, pre-treated and/or resistant to anthracyclines and taxanes | Phase III Blinding NR | 1) CAP 2) VIN + GEM | 172 | To demonstrate superiority of combination treatment in terms of PFS. |
Vahdat, 2013 [20] NCT00879086 | Women with locally recurrent or MBC who had received prior taxane therapy, at least one prior cytotoxic chemotherapy for advanced disease, and progressed during last anti-cancer treatment | Phase II Open-label | 1) ERI 2) IXA | 104 | To assess the incidence of neuropathy. |
CA163–046 NCT00080301 Thomas, 2007 [21] Hortobagyi, 2010 [22] Rugo 2018 [23] | Women with LABC or MBC, pre-treated with or resistant to anthracyclines and taxanes | Phase III Open-label | 1) IXA + CAP 2) CAP | 752 | To describe the results of OS from the CA163–046 phase III study. |
CA163–048 NCT00082433 Sparano 2010 [24] Rugo 2018 [23] | Women previously treated with an anthracycline- and taxane-containing regimen | Phase III Open-label | 1) IXA + CAP 2) CAP | 1221 | To assess whether the combination improved survival compared with CAP monotherapy. |
Zhang 2017 [25] NCT02253459 | Female patients with MBC refractory to anthracycline and taxane | Phase III Open-label | 1) UTI + CAP 2) CAP | 405 | To compare the efficacy and safety of UTI + CAP vs. CAP alone in patients with MBC. |