Hi
@ands and fellow IBX-ers
I've been thinking about posting this for a while just to clarify how - IMO - the trial will run. There's been a lot of discussion about trial commencement, enrolment etc. and it warrants clarification and some further discussion.
Unlike typical pharma trials that involve subject enrolment 'en-mass' and different dosing arms, it's important to understand that the way breast cancer is managed following initial patient presentation is likely to mean this trial will run somewhat differently. From initial presentation - either through a routine mammogram showing up something suspect or a patient discovering a lump in their breast - through to surgery frequently takes less than a week. Some breast cancers are extremely aggressive, persistent and strongly metastatic, so there's no mucking around. Consequently, the notion that there will be a kind of 'enrolment phase' to this trial is unlikely to be true. Instead, I wold suggest that women will be offered the opportunity to participate in the trial in the course of the 'standard of care' - at the point of MRI to identify possible metastases involving sentry lymph nodes in the axilla (the armpit). If correct, this will mean that women will move onto and out of the trial almost one at a time as they undergo treatment. In the event that there is suspected metastases to the lymph nodes, the patient will be injected with our HER2 targeting SPIONS, a MRI scan completed, then the lymph nodes excised for pathology to confirm the cancer. In the event that the cancer is confirmed, the excised tissue will be sent for a Magsense scan in the US.
I'm very happy to be corrected on any aspect of this by those more knowledgable, but I'm fairly confident that the recent references on HC to whether trial enrolment has begun fundamentally misunderstand how things are likely to progress.
A fantastic week - things are certainly starting to hot up.
Have a great weekend all.
