Would you take part in a clinical trial?
So I've been approached by my oncologist to take part in a clinical trial of drug called Ribociclib- from my understanding it is one that has been used in the last few years to treat metsatic BC with...
Forum Discussion
You could be randomised to the intervention (ribociclib) or the placebo. Ricociclib is a CDK4/6 inhibitor like palbociclib (Ibrance). Used to treat metastatic BC, these drugs are undergoing trials to demonstrate their ability to reduce recurrence risk and improve disease-free survival in early BC patients.
Importantly, ask your oncologist about the recent early termination of Pfizer's PALLAS trial. PALLAS's termination was announced about two weeks ago. Its termination is BIG news in the early BC research universe.
PALLAS was designed to assess palbociclib's ability to reduce recurrence and improve disease-free survival in early BC patients. PALLAS enrolled over 5,000 Stage II (Stage IIA was limited to 1,000) and Stage III patients worldwide. Patients took palbociclib for two years with adjuvant endocrine therapy.
A futility analysis determined that the trial goal would not be achieved,i.e. palbociclib added no benefit to standard adjuvant endocrine therapy. Patients still taking palbociclib were informed by their doctors to cease. Pfizer will continue to collect follow-up data from patients who agree.
You raise legitimate concerns about the demands (regular tests, logistics & travel, time commitment, emotional investment, etc.) of participating in a clinical trial. Ask your oncologist their thoughts about the early termination of PALLAS and if there are similar implications for the trial they have suggested to you.
Importantly, ask your oncologist about the recent early termination of Pfizer's PALLAS trial. PALLAS's termination was announced about two weeks ago. Its termination is BIG news in the early BC research universe.
PALLAS was designed to assess palbociclib's ability to reduce recurrence and improve disease-free survival in early BC patients. PALLAS enrolled over 5,000 Stage II (Stage IIA was limited to 1,000) and Stage III patients worldwide. Patients took palbociclib for two years with adjuvant endocrine therapy.
A futility analysis determined that the trial goal would not be achieved,i.e. palbociclib added no benefit to standard adjuvant endocrine therapy. Patients still taking palbociclib were informed by their doctors to cease. Pfizer will continue to collect follow-up data from patients who agree.
You raise legitimate concerns about the demands (regular tests, logistics & travel, time commitment, emotional investment, etc.) of participating in a clinical trial. Ask your oncologist their thoughts about the early termination of PALLAS and if there are similar implications for the trial they have suggested to you.