Active Not Recruiting
OBSERVATIONAL
NCT05377684
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in addition to triptorelin, an endocrine cancer treatment. The study will also get more information about: - the effectiveness and safety of triptorelin; - the relationship that could exist between the characteristics of the disease and the treatment chosen by the Investigator.
Primary Outcomes
Measure:
Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score.
TimeFrame:
At 18 months.
Description:
Defined as a minimum change of ≥4 points using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire.
Trial Information
NCT ID
NCT05377684
Status
Active Not Recruiting
Study Type
OBSERVATIONAL
Sponsor
Ipsen
Last Updated
December 15, 2025