From: Circulating tumor cells in breast cancer: A tool whose time has come of age
Study Design | Primary Objective | Prospective orRetrospective | N | Line of therapy | Median PFS (months) | Median OS (months) |
---|---|---|---|---|---|---|
1. Multi-institution, double-blind, clinical trial of patients with MBC with measurable disease beginning a new therapy. CTCs assessed at baseline and at 1st follow-up clinical visit, approximately 3-4 weeks after starting therapy.14 | PFS, OS | Prospective | 177 | Any | 7.0 vs 2.7; p < 0.001 baseline assessment 7.0 vs 2.1; p < 0.001 1st follow-up | >18 vs 10.1; p < 0.001 baseline assessment >18 vs 8.2; p < 0.001 1st follow-up |
2. Multi-institution, double-blind, clinical trial of patients with MBC with measurable disease on treatment. CTCs assessed at 2nd follow-up and subsequent follow-up clinical visits up to 9 months of follow-up. Sub-study of #1 above.15 | PFS, OS | Prospective | 177 | Any | 5.6 - 7 vs 1.3 - 6; p = n/a | 18.6- >25 vs 6.3 - 10.9; p = 0.001 |
3. Multi-institution, double-blind, clinical trial of patients with MBC with measurable disease beginning a new therapy. CTCs assessed at baseline and 1st follow-up clinical visit, approximately 3-4 weeks after starting therapy for the 47% of patients who were being treated with 1st line palliative therapy. Sub-study of #1 above. 16 | PFS, OS | Prospective | 83 | 1st line | 9.5 vs 4.9, p = 0.0014 baseline assessment 9.5 vs 2.1, p = 0.0057 1st follow-up | >18 vs 14.2, p = 0.0048 baseline assessment >18 vs 11.1, p = 0.0012 1st follow-up |
4. Single institution, retrospective analysis of a cohort of newly diagnosed MBC patients (either with de novo MBC or newly diagnosed recurrent MBC) who had CTCs assessed at the time of initial diagnosis of MBC between 2001 and 2007. CTCs assessed at baseline, prior to starting salvage therapy.17 | OS | Retrospective | 185 | 1st line | Â | 28.3 vs 15, p < 0.001 |
5. Single institution assessment of a cohort of MBC patients prior to starting a new treatment regimen. CTCs assessment correlated with histology and phenotypic subtypes of breast cancer.18 | Exploratory OS | Retrospective | 517 | Any | Â | Â |