Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)
Launched by UNIVERSITY HOSPITAL, BREST · Sep 27, 2024
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
The MONARCHE29 clinical trial is studying the safety and effectiveness of a medication called Abemaciclib when used alongside hormone therapy for patients with a specific type of breast cancer known as RH+ HER2 non-amplified breast cancer. This research is particularly important because, even though hormone therapy has been proven to reduce the risk of cancer returning, some patients still face a significant chance of relapse. The goal of the trial is to gather real-world data on how well Abemaciclib works and how it affects patients' quality of life, especially in those at higher risk of their cancer coming back.
To be eligible for this trial, participants must be adults who have already received Abemaciclib and hormone therapy for their localized breast cancer. They should have certain features, like having at least four affected lymph nodes or a larger tumor size. Those who are under legal protection or refuse to participate are not able to join. Patients in the trial can expect to contribute to valuable research that aims to improve treatment options and outcomes for future patients with similar conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patient
- • Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy
- * Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:
- • 4 ipsilateral positive axillary lymph nodes OR
- • 1. to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm
- Exclusion Criteria:
- • Patients under legal protection (guardianship, trusteeship, etc.)
- • Refusal to participate
About University Hospital, Brest
The University Hospital of Brest is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. With a strong emphasis on interdisciplinary collaboration, the hospital serves as a hub for cutting-edge clinical trials aimed at improving treatment outcomes across various medical specialties. Leveraging its robust academic affiliations and state-of-the-art facilities, the University Hospital of Brest is committed to fostering scientific discovery and enhancing the quality of life for patients through evidence-based practices and pioneering research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brest, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported