Castle, John
Blower, Emma
Bundred, Nigel J.
Harvey, James R.
Thachil, Jecko
Marshall, Andrea
Cox, Karina
Cicconi, Silvia
Holcombe, Chris
Palmieri, Carlos
Kirwan, Cliona C.
Funding for this research was provided by:
National Institute for Health Research (NIHR CS-11-014)
Article History
Received: 28 April 2020
Accepted: 12 August 2020
First Online: 27 August 2020
Ethics approval and consent to participate
: This study has UK National Research Ethics Service (NRES) approval REC reference 15/NW/0406 from the North West - Liverpool Central Research Ethics Committee. Patients must give written informed consent via the document-controlled trial consent form before undergoing any trial-specific screening investigations. Trial sites are responsible for assessing a patient’s capability to give informed consent and ensuring an appropriate member of staff has countersigned and dated the consent form. Patients with planned NAC must consent to undergo a repeat core biopsy once treatment has been completed. Patients will be asked to consent that data are recorded, collected, stored and processed in accordance with the EU Data Protection Directive (95/46/EC). Patients at consent may give permission for stored tissue and/or blood samples to be used for future breast cancer research, which is optional for TIP trial participation. The TIP trial coordinator confirms that eligibility criteria are met, that informed consent is obtained and that these are both documented.This study may be terminated at the request of the Chief Investigator, Independent Data and Safety Monitoring Committee or the Independent Ethics Committee if, during the course of the study, concerns about the safety emerge.
: Not applicable. No intended sharing of deidentified individual clinical trial participant-level data (IPD).
: The authors declare that they have no competing interests.