Declarations
Acknowledgements
The authors gratefully acknowledge the help from Professor John Yarnold
in reviewing the manuscript and providing important help and guidance
during the protocol drafting stage.
Authors’ contributions
{31b}
The HYPORT Adjuvant Author group jointly drafted this manuscript. All
authors read and approved the final manuscript.
Funding {4}
- Intramural funding from Tata Medical Center, Kolkata
- Extramural funding from the WCI-Nag Breast Cancer Research Award 2020.
- Intramural grant from Christian Medical College, Vellore
- Intramural grant from SGPGI, Lucknow
Tata Medical center as the sponsoring institute is responsible for the
drafting of the main protocol as well as the design and conduct of the
trial. Extramural funding sources have no role in collection, analysis
and interpretation of data.
Availability of data and material {29}
The protocol as well as the statistical analysis plans are made
available as supplementary material. Data collected on patients will be
made available based on regulatory norms after reporting of the primary
outcomes.
Ethics Approval and consent to participate {24}
The study has been approved by the Institutional Review Board of Tata
Medical Center vide approval letter number 2018/TMC/133/IRB31 dated 17th
December 2018. Additionally, IRB approval has been obtained from
Christian Medical College, Vellore (IRB Min No 11991, dated 24/04/19)
and Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
(2019-117-EMP-109, 12/06/19). All patients are provided with a patient
information sheet translated into the vernacular language and written
informed consent is obtained before accrual.
Consent for publication
{32}
Not Applicable
Competing Interests {28}
The authors declare that they have no competing interests.
Author details
The following table lists the authors included in the HYPORT Adjuvant
author group.