… pretreated breast cancer patients, we initiated an open-label, multicenter, single-arm, phase
II … of single-agent gemcitabine as first-line therapy in patients with metastatic breast cancer. …

… We conducted a phase II trial to evaluate the efficacy and safety of gefitinib as first-line therapy
for … Patients with stage IIIB or IV chemotherapy-naïve NSCLC with EGFR mutation were …

… This was a multicenter, randomized, open-label, phase II trial to compare PFS in enrolled
patients who received either sorafenib 400 mg twice daily or IFN-α-2a 9 million U three times …

… In Japanese phase II amrubicin studies in second-line treatment of SCLC, a 42% to 56% …
In the randomized phase II trial comparing amrubicin with topotecan as second-line treatment, …

… This phase II study was designed to evaluate the safety and efficacy of the combination of
cetuximab plus oxaliplatin, FU, and LV (FOLFOX-4) as a first-line treatment for patients with …

… Given this background, we decided not to proceed to a phase III trial of FOLFIRINOX
versus FOLFIRI/FOLFOX alone. Instead, we initiated a new large randomized phase II trial to …

… , randomised phase II trial with two treatment arms. Random assignment (1 : 1 ratio) was
centralised and performed by the Coordination Center for Clinical Trials on Gastrointestinal …

… -drug regimen in which fluorouracil was used with folinate, irinotecan, and oxaliplatin (FOLFOXIRI).
Data from phase 2 trials suggested that this regimen was feasible and very active. …

… In this open-label, multicentre, phase 2 trial, we enrolled treatment-naive patients with
advanced lung cancer who had clinical (never-smokers [<100 cigarettes per lifetime] or former …

… our trial … regimen as first‐line therapy. These data are consistent with the encouraging
results we obtained from a multicenter phase II trial evaluating early response to three first‐line …