multiple drugs are rotated in and out. drugs that are non effective get rotated out.
drugs showing more effect have more patients randomized to that arm.
Looking at the record history shows new drugs are rotated in every 3 to 6 months. occasionally shorter/longer. Im assuming when Doc J said "weeks to months" he doesnt mknow exactly how long Pre-Spy takes (if it even must be completed before I spy starts) or how long based on timing it takes to rotate in.
They just updated the trial site a few days (right around out conf call) ago with new arms. like 5/6/26?
a lot of questions are answered in the I-spy website
https://www.quantumleaphealth.org/for-investi...py-trials/
Heres a quick breakdown of how the website lays out the process. Leron will be used on up to 120 patients.
" At consent, a new participant’s breast cancer is classified into one of 6 response predictive molecular subtypes. Then, for each participant in the trial:
1. Randomize to Expt’l or Control Arm
I-SPY 2’s adaptive randomization engine assigns a participant to a study arm; it gives greater weight to arms that have been successful in the participant’s tumor subtype.
2. Patient Outcome (RCB/pCR)
I-SPY 2’s adaptive randomization engine assigns a participant to a study arm; it gives greater weight to arms that have been successful in the participant’s tumor subtype.
3. Update Predictive Probabilities
Based on the participant’s tumor subtype, outcome (i.e. MRI volume, pCR) and treatment received, the predictive probabilities of the agent in the various subtypes are updated in real time.
4. Apply Termination Rules (Per Arm)
If predictive probabilities for an experimental agent reach a pre-determined level of efficacy in one or more molecular subtypes, it is declared a success (“graduates”). Alternatively, it may be stopped for futility after reaching a maximum number of participants.
At any point new agents can enter the trial through a protocol amendment.
5.Update Randomization Probabilities
The participant’s serial MRI measures, RCB scores and tumor subtype are used to update the prior probabilities of the randomization engine — over time this refines the targeting of subsequent participants.
drugs showing more effect have more patients randomized to that arm.
Looking at the record history shows new drugs are rotated in every 3 to 6 months. occasionally shorter/longer. Im assuming when Doc J said "weeks to months" he doesnt mknow exactly how long Pre-Spy takes (if it even must be completed before I spy starts) or how long based on timing it takes to rotate in.
They just updated the trial site a few days (right around out conf call) ago with new arms. like 5/6/26?
a lot of questions are answered in the I-spy website
https://www.quantumleaphealth.org/for-investi...py-trials/
Heres a quick breakdown of how the website lays out the process. Leron will be used on up to 120 patients.
" At consent, a new participant’s breast cancer is classified into one of 6 response predictive molecular subtypes. Then, for each participant in the trial:
1. Randomize to Expt’l or Control Arm
I-SPY 2’s adaptive randomization engine assigns a participant to a study arm; it gives greater weight to arms that have been successful in the participant’s tumor subtype.
2. Patient Outcome (RCB/pCR)
I-SPY 2’s adaptive randomization engine assigns a participant to a study arm; it gives greater weight to arms that have been successful in the participant’s tumor subtype.
3. Update Predictive Probabilities
Based on the participant’s tumor subtype, outcome (i.e. MRI volume, pCR) and treatment received, the predictive probabilities of the agent in the various subtypes are updated in real time.
4. Apply Termination Rules (Per Arm)
If predictive probabilities for an experimental agent reach a pre-determined level of efficacy in one or more molecular subtypes, it is declared a success (“graduates”). Alternatively, it may be stopped for futility after reaching a maximum number of participants.
At any point new agents can enter the trial through a protocol amendment.
5.Update Randomization Probabilities
The participant’s serial MRI measures, RCB scores and tumor subtype are used to update the prior probabilities of the randomization engine — over time this refines the targeting of subsequent participants.
4
