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JOURNAL ONKOLOGIE – STUDIE
ELEANOR

Real-life Pan-HER-blockade With Neratinib

Rekrutierend

NCT-Nummer:
NCT04388384

Studienbeginn:
April 2020

Letztes Update:
11.06.2020

Wirkstoff:
Neratinib

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Pierre Fabre Pharma GmbH

Collaborator:
iOMEDICO AG, Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG,

Studienleiter

Anna Resch
Study Director
Pierre Fabre Pharma GmbH

Kontakt

Studienlocations
(2 von 2)

Medical Practice
38642 Goslar
(Niedersachsen)
GermanyRekrutierend» Google-Maps

Studien-Informationen

Brief Summary:

So far, there is no data available on treatment of patients with early-stage hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago, in the clinical routine setting.

ELEANOR - designed as a prospective, longitudinal, non-interventional study (NIS) - will investigate real-world use of neratinib and its treatment management in patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago. Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting.
 

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent of the patient with regard to the pseudonymized documentation;

- Legally capable female patient ≥ 18 years of age (no upper limit);

- Decision was taken to treat the patient with neratinib in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;

- Treatment with neratinib is planned to be started;

- Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;

- Completion of prior trastuzumab-based therapy less than 1 year ago;

- No signs of relapse before initiation of neratinib treatment.

Exclusion Criteria:

- Presence of any contraindication with regard to the neratinib treatment as specified in the corresponding Summary of Product Characteristics (SmPC);

- Current or upcoming participation in an interventional clinical trial;

- Prisoners or persons who are compulsorily detained (involuntarily incarcerated)

Studien-Rationale

Primary outcome:

1. Patient Compliance (Time Frame - 12 months of treatment):
Rate of patients being compliant to therapy with neratinib. A patient is defined as being compliant, if she has taken the prescribed neratinib dose for at least 75% of the treatment days.



Secondary outcome:

1. Patient profile at baseline (Time Frame - Baseline):
% of patients with different demographic characteristics

2. Disease profiles at baseline (Time Frame - Baseline):
% of patients with different disease characteristics

3. Pretreatment characteristics at baseline (Time Frame - Baseline):
% of patients with different pretreatments

4. Reason for neratinib treatment (Time Frame - Baseline):
% of patients with different reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)

5. Neratinib treatment characteristics (Time Frame - 12 months of treatment):
Absolute and relative dose intensity

6. Neratinib treatment characteristics (Time Frame - 12 months of treatment):
% of patients with dose modification

7. Neratinib treatment characteristics (Time Frame - 12 months of treatment):
% of patients with different reasons for dose modification (toxicity, concomitant disease, patient's wish, treatment holiday, other)

8. Neratinib treatment characteristics (Time Frame - 12 months of treatment):
% of patients with different concomitant medications

9. Relapse of disease (Time Frame - through study completion; maximum follow-up 55 months):
% of patients with relapse of disease

10. Patient reported outcome - EQ-5D-5L (Time Frame - 12 months of treatment):
The EQ-5D-5L is a standardized instrument for use as a measure of general health status preferences. It measures 5 dimensions of health including mobility, self-care, pain/discomfort, anxiety, and general health via a horizontal visual analog scale. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status.

11. Patient reported outcome - STIDAT (Time Frame - 12 months of treatment):
The Systemic Therapy Induced Diarrhea Assessment Tool (STIDAT) questionnaire is a validated, patient-reported assessment tool designed to accurately identify the presence of diarrhea and its severity using multiple bowel habit dimensions in patients with systemic therapy-induced diarrhea (STID) of multiple solid tumors who received systemic therapy with or without radiation.

12. Physicians' treatment satisfaction: 5 point scale (Time Frame - 12 months of treatment):
% of patients with different physician satisfaction scores (5 point scale from very dissatisfied to very satisfied)

13. Patients' treatment satisfaction: 5 point scale (Time Frame - 12 months of treatment):
% of patients with different patient satisfaction scores (5 point scale from very dissatisfied to very satisfied)

14. Safety and tolerability of treatment with neratinib (Time Frame - 12 months of treatment + 30 days of safety follow-up):
% of patients with adverse events overall

15. Safety and tolerability of treatment with neratinib (Time Frame - 12 months of treatment + 30 days of safety follow-up):
% of patients with adverse events by intensity

16. Safety and tolerability of treatment with neratinib (Time Frame - 12 months of treatment + 30 days of safety follow-up):
Time to onset of first adverse event

17. Safety and tolerability of treatment with neratinib (Time Frame - 12 months of treatment + 30 days of safety follow-up):
Duration of adverse events

18. Safety and tolerability of treatment with neratinib (Time Frame - 12 months of treatment + 30 days of safety follow-up):
% of patients with action taken against adverse events

Geprüfte Regime

  • Neratinib:
    Neratinib standard dose 240 mg once daily for 1 year

Quelle: ClinicalTrials.gov


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