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Advances include the development and application of CyTOF and high-throughput sequencing for evaluating cellular function and responses and the translation of important concepts to the clinic in promising early phase clinical trials.
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Based on promising early results, one phase II study is examining the safety, tolerability and response rate of the combination of trastuzumab and everolimus in patients with HER2-overexpressing breast cancer with trastuzumab-refractory metastatic disease [ 16].
Without government funding or sponsorship, some promising early-phase oncology trials lost the opportunity to be further academically developed.
Based on these promising early-phase clinical data in HER2-positive MBC, phase-III trials of trastuzumab/paclitaxel±everolimus in the first-line setting (BOLERO-1; NCT00876395) and trastuzumab/vinorelbine±everolimus in the trastuzumab-refractory setting (BOLERO-3; NCT01007942) are in progress.
Despite promising early results [ 97, 98], a phase III trial of tirapazamine in combination with radiation therapy showed no significant difference in failure-free survival, time to locoregional failure, or quality of life [ 99].
Another combination Empatic™ (buproprion and the antiepileptic zonisamide) has completed Phase IIb [9] and both these agents show promising early efficacy signals.
Blendle is a promising early example.
with promising early results [ 15].
Phase 1 and 2 clinical trials utilizing the PSMA monoclonal antibody J591, radiolabeled with Y or Lu have shown promising early results [ 7– 11].
There have been promising early results.
Based on insights into the basic pathophysiological mechanisms of the disorder, some drugs have been developed which seem promising in early phase II studies (NOS inhibitors and 5HT1F-receptor agonists).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com