Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer (HERMIONE-10)
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- STATUS
- Recruiting
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- End date
- Mar 20, 2023
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- participants needed
- 200
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- sponsor
- University of Milano Bicocca
Summary
Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting.
Description
The study, multicenter, retrospective and prospective, cohort, observational, describes the modalities of treatment with Eribulin as a second line therapy for triple negative breast cancer and "clinical outcomes" in a population real-world, evaluating any differences with the results obtained in clinical trials. Therapeutic sequences will also be evaluated with the aim of providing a photograph of the choices made in clinical practice in this historical moment characterized by rapid evolution of new molecules available to clinicians.
A total of at least 200 patients with triple negative advanced breast cancer treated with Eribulin as second line will be enrolled in the retrospective or prospective cohort. Enrollment period will last 2 years.
Pseudoanonymized data will be collected in a electroctronic database (RedCap Cloud); here the list of the main variables collected:
- Patient Registration
- Demography
- Pregnancy test
- Past history and habits of the patient
- Previous antineoplastic therapy
- Anamnesis close to entering the study
- Vital signs and ECOG performance status (WHO)
- Blood chemistry tests
- RECIST 1.1 Baseline and re-evaluations
- 12 Lead ECG evaluation
- Eribulin cycles
- Adverse events
- Previous and concomitant medications
- End of study
The retrospective analysis of the choices made in clinical practice and the benefits obtained from the second therapeutic lines could provide important data to favor the definition of prospective randomized studies, and guide the clinician towards a better therapeutic path.
Details
| Condition | Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer |
|---|---|
| Clinical Study Identifier | NCT05302778 |
| Sponsor | University of Milano Bicocca |
| Last Modified on | 20 April 2022 |
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