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}

  1. Intramural funding from Tata Medical Center, Kolkata
  2. Extramural funding from the WCI-Nag Breast Cancer Research Award 2020.
  3. Intramural grant from Christian Medical College, Vellore
  4. 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.