Treatment, stratification, randomization, data
toxicity, death, Tumor
DISEASE PROGRESSION, TUMOR, ADVERSE EVENTS, ADVERSE EVENT, EVENT, RECURRENT DISEASE, PRIMARY TUMOR, BLOOD
Patients allocated to the combination of palbociclib with aromatase inhibitor receive:Palbociclib, 125 mg, orally once daily on day 1 to day 21 of every 28-day cycle followed by 7 days off treatment andAromatase inhibitor, orally once-daily (continuously).Pre- or peri-menopausal patients should additionally receive a LHRH-agonistPatients allocated to the combination of palbociclib with fulvestrant receive:Palbociclib, 125 mg, orally once daily on day 1 to day 21 of every 28-day cycle followed by 7 days off treatment andFulvestrant, 500 mg, intramuscularly on days 1 and 14 of cycle 1, every 28 days (± 7 days) thereafter starting.Pre- or peri-menopausal patients should additionally receive a LHRH-agonistParticipants are randomly assigned to either experimental (“CANKDO active”) or control group (“CANKADO inform”) with a 2:1 allocation as per a computer-generated randomization schedule stratified by site and prior therapy line (first line vs. later line) using permuted blocks of random sizes. The block sizes are not disclosed, to ensure concealment. Randomization lists are created by the sponsor biostatistics department and forwarded to the sponsor randomization center. Figure Patient assignment to the PreCycle study arms is managed centrally by a combined process involving the CANKADO system and the eCRF. After a patient has signed the ICF and screening measurements have been completed, patient baseline data have to be documented in eCRF by site personnel. Then, the site creates a patient account in CANKADO. The CANKADO system generates a patient-specific CANKADO trial ID which is part of the baseline documentation at the eCRF. The patient-specific CANKADO trial ID is the link between the two systems. When baseline documentation is completed, the site can request patient enrollment at the sponsor randomization center via phone or email. The randomization center assigns the study arm according to site specific randomization lists via eCRF and in parallel to the patient account in the CANKADO system. Afterwards, the site activates patient’s CANKADO account.Patients continue to receive study treatment together with the assigned ePRO assessment until investigator assessed disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.Adverse events (AEs) and serious adverse events (SAEs) are collected throughout palbociclib treatment and 28 days after the last dose. When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation (e.g., hospital progress notes, laboratory reports, and diagnostics reports) related to the event. The investigator then record all relevant AE/SAE information in the eCRF.Patients discontinuing the active treatment phase enter a follow-up period phase; further progression and new anti-cancer therapy information are collected once a year up to 48 months after randomization.In addition, biomarkers are assessed as a scientific translational program within this study. Tumor material from available primary tumor and/or available biopsies from recurrent disease are collected. Blood samples are collected at four time points during the study when also routine blood samples are mandatory (see Fig. PreCycle—schedule of investigationsAll study treatments are approved treatments following clinical standards and local guidelines.