Status:
UNKNOWN
Implementing Patients´ Competence in Oral Breast Cancer Therapy
Lead Sponsor:
Onco Medical Consult GmbH
Collaborating Sponsors:
Eli Lilly and Company
Institut fuer Frauengesundheit
Conditions:
Metastatic Breast Cancer
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the IMPACT - Implementing Patients' competence in oral breast cancer therapy - study is to evaluate the effectiveness of a standardized patient education and coaching and optional eMBSR for...
Detailed Description
Breast cancer therapy has advanced by far over the last decade. Introduction of novel therapies as well as the introduction of mammography screening are thought to have reduced mortality over the last...
Eligibility Criteria
Inclusion
- Adult breast cancer patients (age ≥18 years).
- Patients with HR+, HER2- advanced or metastatic breast cancer proven by clinical measures (i. e. standard imaging) whose disease has progressed after hormonal therapy in combination with fulvestrant, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy (advanced disease must not be amenable to resection with curative intent).
- Patients treated with Abemaciclib according to the SmPC and each center´s medical practice.
- Informed consent prior to onset of documentation.
Exclusion
- Patients with serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Females who are pregnant or lactating.
- Patients with active bacterial infections (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
- Patients with a personal history in the past 5 years of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- Patients with contraindications against Abemaciclib according to respective SmPC´s.
- Patients who are not eligible for observation due to severe comorbidities other then mentioned above or unavailability according to the treating physician.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04030728
Start Date
March 1 2020
End Date
December 1 2021
Last Update
February 5 2020
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