Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHellenic Cooperative Oncology Group
About this trial
The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed HR-positive, HER2-negative breast cancer
Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
18 years or older
Any menopausal status
Disqualifiers
None
Trial population
Patients with histologically confirmed HR-positive, HER2-negative breast cancer treated with abemaciclib in combination with endocrine therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
108 Participants
are grouped into 2 trial groupsGroup A: Patients with breast cancer randomised in arm A of digital platform
Group B: Patients with breast cancer randomised in arm B of digital platform
Trial outcomes
Primary outcomes
1
Progression-free survival
the time from treatment initiation to either the first documented disease progression or death from any cause
Time frame
Through the completion of the study, for an average of 6 monthsSecondary outcomes
1
Overall survival
The time from treatment initiation to patient death or last contact
Time frame
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months2
Efficacy of the digital support through personalised support in patients with BC
Time frame
Up to 30 months3
Toxicity rate
Adverse events from the time from treatment initiation to disease progression, patient death or last contact
Time frame
Up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov