Integration of translational research in phase III trials: a systemic review of breast cancer studies in a 5-year period
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Background:
Samples' collection for translational analyses in phase III trials requires a huge effort and there is no evidence on how it translates into new knowledge on tumour biology or optimization of patients’ selection. We systematically reviewed phase III trials in breast cancer (BC) to evaluate how frequently a translational project has been integrated into their design and how this integration translated into new translational evidence.
Methods:
Interventional phase III trials evaluating anticancer drugs in BC published in 11 major journals between 2014 and 2018 were included.
Results:
89 BC phase III trials were identified, 3 had no sample collection. Among the others, in 36 % the information on sample collection for research purposes was not clear while more than half of the samples had definitive evidence of it.
After a median follow-up of 87.9 months, 55.8 % studies published translational data with a mean number of 1.31 (SD 1.7) and 1.07 (SD 1.8), congress abstracts and secondary papers, respectively.
There was a higher probability of published translational results for studies with positive outcomes (68.6 % vs 47.1 %), clear evidence of sample collection (72.2 % vs 28.1 %), well-established translational endpoint (73 % vs 42.9 %) and higher impact factor journal (IF) for the clinical publications (64.5 % vs 33.3 %). Secondary translational papers were usually published in lower IF journals with a significant delay from the clinical publication.
Conclusions:
Although extremely resource-demanding, sample collections for translational analyses in phase III trials are frequently not well defined, and only 50 % produce new translational evidence, which is delayed in time and published in lower IF journals.
Samples' collection for translational analyses in phase III trials requires a huge effort and there is no evidence on how it translates into new knowledge on tumour biology or optimization of patients’ selection. We systematically reviewed phase III trials in breast cancer (BC) to evaluate how frequently a translational project has been integrated into their design and how this integration translated into new translational evidence.
Methods:
Interventional phase III trials evaluating anticancer drugs in BC published in 11 major journals between 2014 and 2018 were included.
Results:
89 BC phase III trials were identified, 3 had no sample collection. Among the others, in 36 % the information on sample collection for research purposes was not clear while more than half of the samples had definitive evidence of it.
After a median follow-up of 87.9 months, 55.8 % studies published translational data with a mean number of 1.31 (SD 1.7) and 1.07 (SD 1.8), congress abstracts and secondary papers, respectively.
There was a higher probability of published translational results for studies with positive outcomes (68.6 % vs 47.1 %), clear evidence of sample collection (72.2 % vs 28.1 %), well-established translational endpoint (73 % vs 42.9 %) and higher impact factor journal (IF) for the clinical publications (64.5 % vs 33.3 %). Secondary translational papers were usually published in lower IF journals with a significant delay from the clinical publication.
Conclusions:
Although extremely resource-demanding, sample collections for translational analyses in phase III trials are frequently not well defined, and only 50 % produce new translational evidence, which is delayed in time and published in lower IF journals.
Date Issued
2025-06-01
Date Acceptance
2025-02-26
Citation
The Breast, 2025, 81
ISSN
0960-9776
Publisher
Elsevier
Journal / Book Title
The Breast
Volume
81
Copyright Statement
© 2025 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by- nc-nd/4.0/).
Identifier
10.1016/j.breast.2025.104431
Publication Status
Published
Article Number
ARTN 104431
Date Publish Online
2025-03-05