Observational study on the safety of Abemaciclib with hormone therapy for breast cancer
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
This study is testing how safe the cancer drug Abemaciclib is when used with hormone therapy for people with high-risk hormone receptor-positive breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT06621459 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and toxicity management of Abemaciclib when used in combination with adjuvant hormone therapy for patients with high-risk hormone receptor-positive, HER2 non-amplified breast cancer. It focuses on patients who have received this treatment and aims to assess treatment tolerance, recurrence-free survival, and the impact of dose reductions on efficacy. The study will analyze real-life data from multiple centers to provide insights into the management of side effects and overall treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult patients with localized hormone receptor-positive, HER2 non-amplified breast cancer who have received adjuvant Abemaciclib in combination with hormone therapy.
Not a fit: Patients under legal protection or those who refuse to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for patients with high-risk breast cancer, potentially improving their survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with CDK4/6 inhibitors like Abemaciclib in metastatic settings, indicating potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest
- Chu Brest — Brest, France (Recruiting)
Study contacts
- Study coordinator: Emmanuelle RENAUD
- Email: emmanuelle.renaud@chu-brest.fr
- Phone: 0298223396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.