Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
- Conditions
- Early-stage Breast Cancer
- Registration Number
- NCT05377684
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score. At 18 months. Defined as a minimum change of ≥4 points using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire.
- Secondary Outcome Measures
Name Time Method Percentage of days covered of compliance At 18 months Description of breast cancer treatment. At baseline. Including triptorelin formulation (1-month or 3-month formulation), planned neoadjuvant/adjuvant chemotherapy (yes/no) and oral adjuvant endocrine treatment prescribed ((Aromatase Inhibitor (AI) or Tamoxifen (TAM))
Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of suboptimal OFS. At 18 months. as per local definition, or empirically defined as E2 levels ranging between 30 and 70 pg/ml according to the average range collected in Italian centers. A multivariate logistic regression will be used to identify predictive factors of suboptimal OFS as per local definition
Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of clinically significant global QoL change At 6, 12 and 18 months. A multivariate logistic regression will be used to identify any predictive factors of clinically significant global QoL change (i.e. ≥4 points).
Incidence of all treatment-emergent adverse events (TEAEs) From baseline up to 18 months. Summary incidence tables of nonserious and serious AEs, as well as special situations presented overall, by System Organ Class and Preferred term (MedDRA coding) and according to intensity and causality
Identification of demographic and tumor characteristics correlated to the entire prescribed breast cancer treatment. At 18 months. A multivariate logistic regression will be used to identify characteristics correlated to the prescription of the 1-month or 3-month triptorelin formulations with TAM or an AI.
Tumor characteristics. At baseline. Proportion of compliant patients (100% of the planned injections) to triptorelin At 18 months. Description of demographic data At baseline. Including Body Mass Index calculation
Identification of potential demographic factors predictive of any treatment switch. At 18 months. A multivariate logistic regression will be used to identify demographic factors predictive of any treatment switches.
Proportion of participants who switch between triptorelin formulations, from AI to TAM or vice-versa, or undergo both triptorelin and adjuvant therapy switches At 18 months. The switches between triptorelin formulation or from the AI to TAM will be described together with the reasons for switches.
Proportion of disease-free participants. At 18 months. Disease-free survival is defined as the time from triptorelin initiation to disease recurrence as determined by the Investigator.
Proportion of participants alive. At 18 months. The OS rate will be estimated using the Kaplan-Meier method. Survival time will be defined as the time from triptorelin initiation to participant's death for any reason.
Change in the Quality of Life (QoL) score using the FACT-G questionnaire with the Endocrine Symptoms (ES) subscale. From baseline and at 6, 12 and 18 months All global scores and subscores of the QoL questionnaire will be described at each timepoint. Comparisons will be performed using the paired Student t-test.
Description of demographic data. At baseline. Including age at diagnosis, parity, pregnancy desire (yes/no), oocyte cryopreservation (yes/no) and embryo cryopreservation (yes/no);
Proportion of participants with hormonal levels (E1, E2 and FSH) corresponding to Ovarian Function Suppression (OFS) From baseline up to 18 months. As per local definition, or empirically defined as E2 levels \<30 pg/ml according to the average level collected in Italian centers)
Trial Locations
- Locations (22)
Istituto Oncologico del Mediterraneo (IOM)
🇮🇹Viagrande, Italy
Ospedale "S. Bortolo"
🇮🇹Vicenza, Italy
Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Ospedale Oncologico "A. Businco"
🇮🇹Cagliari, Italy
Azienda Ospedaliero-Universitaria Careggi (AOUC)
🇮🇹Firenze, Italy
ASST Lecco
🇮🇹Lecco, Italy
IRCCS San Raffaele
🇮🇹Milano, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Istituto Nazionale Tumori
🇮🇹Milano, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Ospedale S. Gerardo
🇮🇹Monza, Italy
AORN Cardarelli
🇮🇹Napoli, Italy
Istituto Nazionale Tumori - Fondazione Pascale
🇮🇹Napoli, Italy
Università della Campania "L. Vanvitelli"
🇮🇹Napoli, Italy
P.O. Ospedale del Mare
🇮🇹Napoli, Italy
Ospedale San Carlo
🇮🇹Potenza, Italy
Ospedale Santa Maria delle Grazie
🇮🇹Pozzuoli, Italy
Policlinico Universitario A. Gemelli (Site A)
🇮🇹Roma, Italy
Policlinico Universitario A. Gemelli (Site B)
🇮🇹Roma, Italy
Humanitas Cancer Center
🇮🇹Rozzano, Italy
Ospedale G. Battista - Molinette
🇮🇹Torino, Italy
ASST BG OVEST Ospedale di Treviglio
🇮🇹Treviglio, Italy