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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score. | Defined as a minimum change of ≥4 points using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. | At 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor characteristics. | At baseline. | |
| Percentage of days covered of compliance | At 18 months | |
| Description of breast cancer treatment. |
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Inclusion Criteria :
Exclusion Criteria :
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The study is aimed at premenopausal participants diagnosed with HR-positive and HER2 negative early breast cancer who are starting treatment with triptorelin at the discretion of the treating physician and who consent to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical, Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S. Orsola - Malpighi | Bologna | 40138 | Italy | |||
| Ospedale Oncologico "A. Businco" |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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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)) |
| At baseline. |
| Identification of potential demographic factors predictive of any treatment switch. | A multivariate logistic regression will be used to identify demographic factors predictive of any treatment switches. | At 18 months. |
| Identification of demographic and tumor characteristics correlated to the entire prescribed breast cancer treatment. | 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. | At 18 months. |
| Proportion of participants who switch between triptorelin formulations, from AI to TAM or vice-versa, or undergo both triptorelin and adjuvant therapy switches | The switches between triptorelin formulation or from the AI to TAM will be described together with the reasons for switches. | At 18 months. |
| Proportion of disease-free participants. | Disease-free survival is defined as the time from triptorelin initiation to disease recurrence as determined by the Investigator. | At 18 months. |
| Proportion of participants alive. | 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. | At 18 months. |
| Proportion of compliant patients (100% of the planned injections) to triptorelin | At 18 months. |
| Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of suboptimal OFS. | 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 | At 18 months. |
| Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of clinically significant global QoL change | A multivariate logistic regression will be used to identify any predictive factors of clinically significant global QoL change (i.e. ≥4 points). | At 6, 12 and 18 months. |
| Incidence of all treatment-emergent adverse events (TEAEs) | 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 | From baseline up to 18 months. |
| Change in the Quality of Life (QoL) score using the FACT-G questionnaire with the Endocrine Symptoms (ES) subscale. | 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. | From baseline and at 6, 12 and 18 months |
| Description of demographic data. | Including age at diagnosis, parity, pregnancy desire (yes/no), oocyte cryopreservation (yes/no) and embryo cryopreservation (yes/no); | At baseline. |
| Description of demographic data | Including Body Mass Index calculation | At baseline. |
| Proportion of participants with hormonal levels (E1, E2 and FSH) corresponding to Ovarian Function Suppression (OFS) | As per local definition, or empirically defined as E2 levels <30 pg/ml according to the average level collected in Italian centers) | From baseline up to 18 months. |
| Cagliari |
| 9121 |
| Italy |
| Azienda Ospedaliero-Universitaria Careggi (AOUC) | Florence | 50134 | Italy |
| ASST Lecco | Lecco | 23900 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy |
| IRCCS San Raffaele | Milan | 20132 | Italy |
| Istituto Europeo di Oncologia | Milan | 20132 | Italy |
| Istituto Nazionale Tumori | Milan | 20133 | Italy |
| Ospedale S. Gerardo | Monza | Italy |
| AORN Cardarelli | Naples | 80131 | Italy |
| Istituto Nazionale Tumori - Fondazione Pascale | Naples | 80131 | Italy |
| Università della Campania "L. Vanvitelli" | Naples | 80138 | Italy |
| P.O. Ospedale del Mare | Naples | 80147 | Italy |
| Ospedale San Carlo | Potenza | 85100 | Italy |
| Ospedale Santa Maria delle Grazie | Pozzuoli | 80078 | Italy |
| Policlinico Universitario A. Gemelli (Site A) | Roma | 168 | Italy |
| Policlinico Universitario A. Gemelli (Site B) | Roma | 168 | Italy |
| Humanitas Cancer Center | Rozzano | Italy |
| Ospedale G. Battista - Molinette | Torino | Italy |
| ASST BG OVEST Ospedale di Treviglio | Treviglio | 24047 | Italy |
| Istituto Oncologico del Mediterraneo (IOM) | Viagrande | 95029 | Italy |
| Ospedale "S. Bortolo" | Vicenza | 36100 | Italy |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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