Real-world Clinical Outcome and Toxicity Data in Patients With Breast Cancer Treated With Abemaciclib Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• Treatment with abemaciclib in combination with endocrine therapy
• Any endocrine therapy
• At least two months of treatment with abemaciclib
Locations
Other Locations
Greece
Hellenic Oncology Cooperative Group
RECRUITING
Athens
Contact Information
Primary
Elena Fountzilas, MD, PhD
FOUNTZILA@ONCOGENOME.GR
+306945779709
Backup
Areti Stamboliou
a_stampoliou@hecog.ondsl.gr
+302106912520
Time Frame
Start Date: 2021-10-06
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 108
Treatments
Patients with breast cancer randomised in arm A of digital platform
Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm A of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician.
Patients with breast cancer randomised in arm B of digital platform
Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm B of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported.
Related Therapeutic Areas
Sponsors
Leads: Hellenic Cooperative Oncology Group