Funding for this research was provided by:
Swiss Cancer Research (KFS-4105-02-2017-R)
Krebsliga Beider Basel (KLbB-4181-03-2017)
Rising Tide Foundation for Clinical Cancer Research (Not applicable)
Fond'action contre le cancer (Not applicable)
Received: 3 September 2018
Accepted: 25 October 2018
First Online: 4 December 2018
Ethics approval and consent to participate
: The TAXIS study protocol SAKK 23/16 – IBCSG 57–18 – ABCSG-53, the patient information and consent form, as well as all other trial-related documents have been approved by the Lead EC for Northwest/Central Switzerland (EKNZ) in agreement with local legal requirements for formal authorization. The Lead EC authorization number is: 2018–00838. Any amendment to the protocol or patient information and consent form will be submitted for authorization to these institutions. Any substantial amendment to the protocol (except for safety reasons) can only be implemented at a site after obtaining written authorization by the corresponding regulatory bodies.Patient recruitment only took place after the site had officially been opened for accrual by the SAKK CC. Sites in Switzerland have to adhere to the Swiss Human Research Act and all applicable local regulatory guidelines. Sites in foreign countries have to adhere to national law and locally applicable regulatory guidelines. Central ethical approval has been confirmed from the Lead EC for Northwest/Central Switzerland (authorization number: 2018–00838) and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained.TAXIS is carried out in accordance with the principles enunciated in the current version of the Declaration of Helsinki, the guidelines of Good Clinical Practice (GCP) issued by the ICH, the applicable Swiss Human Research Act and its associated ordinances and the requirements from the Swiss and European regulatory bodies [CitationRef removed–CitationRef removed].
: Not applicable.
: The authors declare that they have no competing interests.
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