This study was a companion study to CLEE011A2404 which provided the opportunity for the
collection of tumor tissue samples to better understand relevant mutations and the
mechanisms responsible for resistance to treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03050398.
This was a multicenter, non-treatment based companion sample collection protocol
conducted in the US only. This protocol sought to evaluate the aberrations of common
pathways for newly diagnosed HR+/HER2- advanced breast cancer tumors and responses to
ribociclib in diverse patient populations. This companion sample collection protocol was
available for all US patients enrolled on CLEE011A2404 (CompLEEment-1) and did not alter
the planned treatment. Tumor collection required for this study occurred at two time
points: at baseline/screening and upon the development of progressive disease as shown in
the protocol. Patients eligible for this companion study were required to sign an
optional additional consent form at the time of enrolling into the core trial.
After eight patients had consented and samples had been taken, it was determined that the
companion study protocol had not been properly initiated or monitored at the sites. This
was determined to be a significant GCP violation and the clinical team made the decision
to terminate the trial. In addition to the GCP issues, enrollment had been closed to the
core study so enrolling additional patients was no longer possible. The limited number of
samples would not provide any meaningful analysis. The samples were never analyzed. The
study was not terminated due to safety or efficacy concerns. Samples collected were
either destroyed or will be retained for up to 15 years based upon the decision of the
patient.
Trial PhasePhase III
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNovartis Pharmaceuticals Corporation
