If toxicity, activity and feasibility are found to be unacceptable recruitment into the trial will stop.
The present study assessed the activity and feasibility of trabectedin in women with advanced breast cancer previously treated with conventional therapies.
During Phase II of the study, the trial will assess toxicity (unexpected and expected), activity and feasibility in 90 patients in the experimental arm.
Our study, despite the small number of patients, is the first prospective report on the activity and feasibility of a maintenance combination of bevacizumab with hormonal therapy in bevacizumab-pretreated women.
To test activity and feasibility of such a combination, a multi-institutional phase II study was initiated in November 1996 by the Italian Group for the study of Digestive Tract Cancer (GISCAD).
Another phase II study, which evaluated the activity and feasibility of first-line capecitabine (825 mg m−2 twice daily on days 1 14) plus paclitaxel (175 mg m−2 on day 1) every 3 weeks in advanced gastric cancer, showed similar results to ours, with an ORR of 53% and a median survival of 14.6 months (Kang et al, 2004).
The fourth component is reported separately 25 and describes a mixed quantitative and qualitative methods process evaluation to evaluate telephone call activity, intervention feasibility, acceptability and fidelity from the perspectives of women, the feeding team and postnatal hospital and community staff.
In the phase II study, we investigated the clinical activity and the feasibility of this chemotherapy regimen.
The conclusion sought may be definitive or practice-changing, a phase III-type question, or it might be feasibility, activity or treatment selection, a phase II-type question.
The fact that the main effectors of this pathway significantly correlate with disease activity suggests the feasibility of choosing patients that may benefit from targeting this molecular pathway.
