Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04985058
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2021-07-26
Brief Title:
Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
Sponsor:
Hellenic Cooperative Oncology Group
Organization:
Hellenic Cooperative Oncology Group
Study Overview
Official Title:
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
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HE11AB21
Brief 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
Detailed Description:
Protocol was amended in November 2021 after the recent FDA approval of abemaciclib in the adjuvant setting On October 12 2021 FDA approved abemaciclib with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive HER2-negative node-positive early breast cancer at high risk of recurrence and a Ki-67 score 20 Our study will now include real-world data on efficacy and toxicity of abemaciclib in the adjuvant setting as well 2-negative advanced breast cancer Patients who are enrolled and the patients to be enrolled will refer to a dedicated online platform CARE ACROSS platform where they can register their side-effects of cancer and the treatment received at frequent intervals Patients will be randomized in the platform in two arms with an allocation 11automatically by the platform After every report of their side-effects patients in Arm A will receive an acknowledgement and suggestion to stay in contact with their clinician After every report of their side- effects patients in Arm B will receive an acknowledgment 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 Clinicians involved in the trial will refer patients upon enrollment or to those already enrolled to a dedicated online platform Patients will sign up by entering their patient ID and their email address and picking their password for security
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None