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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05377684




Registration number
NCT05377684
Ethics application status
Date submitted
29/04/2022
Date registered
17/05/2022

Titles & IDs
Public title
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
Scientific title
Noninterventional, Multicentre, Prospective, Cohort Study Assessing the Quality of Life and Hormonal Levels in Premenopausal Patients With Hormone Receptor-positive and HER2-negative Early Breast Cancer in Italy - ROSE Study
Secondary ID [1] 0 0
CLIN-52014-452
Universal Trial Number (UTN)
Trial acronym
ROSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early-stage Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score.
Timepoint [1] 0 0
At 18 months.
Secondary outcome [1] 0 0
Tumor characteristics.
Timepoint [1] 0 0
At baseline.
Secondary outcome [2] 0 0
Percentage of days covered of compliance
Timepoint [2] 0 0
At 18 months
Secondary outcome [3] 0 0
Description of breast cancer treatment.
Timepoint [3] 0 0
At baseline.
Secondary outcome [4] 0 0
Identification of potential demographic factors predictive of any treatment switch.
Timepoint [4] 0 0
At 18 months.
Secondary outcome [5] 0 0
Identification of demographic and tumor characteristics correlated to the entire prescribed breast cancer treatment.
Timepoint [5] 0 0
At 18 months.
Secondary outcome [6] 0 0
Proportion of participants who switch between triptorelin formulations, from AI to TAM or vice-versa, or undergo both triptorelin and adjuvant therapy switches
Timepoint [6] 0 0
At 18 months.
Secondary outcome [7] 0 0
Proportion of disease-free participants.
Timepoint [7] 0 0
At 18 months.
Secondary outcome [8] 0 0
Proportion of participants alive.
Timepoint [8] 0 0
At 18 months.
Secondary outcome [9] 0 0
Proportion of compliant patients (100% of the planned injections) to triptorelin
Timepoint [9] 0 0
At 18 months.
Secondary outcome [10] 0 0
Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of suboptimal OFS.
Timepoint [10] 0 0
At 18 months.
Secondary outcome [11] 0 0
Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of clinically significant global QoL change
Timepoint [11] 0 0
At 6, 12 and 18 months.
Secondary outcome [12] 0 0
Incidence of all treatment-emergent adverse events (TEAEs)
Timepoint [12] 0 0
From baseline up to 18 months.
Secondary outcome [13] 0 0
Change in the Quality of Life (QoL) score using the FACT-G questionnaire with the Endocrine Symptoms (ES) subscale.
Timepoint [13] 0 0
From baseline and at 6, 12 and 18 months
Secondary outcome [14] 0 0
Description of demographic data.
Timepoint [14] 0 0
At baseline.
Secondary outcome [15] 0 0
Description of demographic data
Timepoint [15] 0 0
At baseline.
Secondary outcome [16] 0 0
Proportion of participants with hormonal levels (E1, E2 and FSH) corresponding to Ovarian Function Suppression (OFS)
Timepoint [16] 0 0
From baseline up to 18 months.

Eligibility
Key inclusion criteria
Inclusion Criteria :

* Premenopausal (as per local definition) female patients aged =18 years on the day the informed consent is signed;
* Patients have histologically proven, HR-positive and HER2 negative breast cancer according to local definition, determined by immunohistochemistry, and up to stage IIIA. Note: patients with synchronous bilateral breast cancer and patients with breast cancer (BRCA)1/2 gene mutations are eligible;
* Patients have been prescribed adjuvant endocrine treatment with TAM or an AI plus triptorelin (either the 1 month or 3 month formulation) by their treating physician or, in alternative, triptorelin given in combination or consequent to neoadjuvant/adjuvant chemotherapy. Note: the decision to prescribe triptorelin is made by the treating physician prior to and independently of the decision to enroll the patient in this study;
* Patients must be documented to be disease-free at enrolment, as determined by the treating physician according to institutional standards. Note: in case the patient has been prescribed neoadjuvant treatment, the patient will receive surgery and be enrolled but will only remain in the study if disease-free condition is confirmed after surgery. If this condition is not confirmed, then the patient will be discontinued from the study;
* Written informed consent for trial participation must be signed and dated by the patient and the Investigator prior to enrolment;
* Patients have been informed of and agree to data transfer and handling, in accordance with national data protection guidelines;
* Patients must be accessible for follow-up;
* Patients may have received previous treatment with triptorelin for another indication, but the last administration must have occurred at least 6 months before enrolment.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria :

* Patient is currently enrolled in any other clinical study or has participated in one within the 12 weeks prior to the Inclusion visit, or is scheduled to receive a new investigational drug while this study is ongoing;
* Patient is not eligible for triptorelin treatment as guided by the product's label in Italy due to safety concerns or has prior history of no responsiveness to triptorelin (in case of previous triptorelin treatment);
* Patient has premenopausal status that cannot be defined;
* Patient has had bilateral oophorectomy or ovarian irradiation;
* Patient has current loco-regional relapse and/or distant metastatic disease;
* Patient has a history of prior (ipsi- and/or contralateral) invasive breast cancer;
* Patient has a history of malignancy other than invasive breast cancer, with the following exceptions: (a) Patients diagnosed, treated and disease-free for at least 5 years and deemed by the Investigator to be at low risk for recurrence of that malignancy are eligible; (b) Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: in situ breast ductal carcinoma; in situ cervical cancer; in situ thyroid cancer; nonmetastatic, no melanomatous skin cancers;
* Patient has concurrent disease or condition that would make study participation inappropriate or any serious medical disorder that would interfere with the patient's safety;
* Patient has psychiatric, addictive, or any other disorder that would prevent compliance with protocol requirements

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
419
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Bologna
Country [2] 0 0
Italy
State/province [2] 0 0
Cagliari
Country [3] 0 0
Italy
State/province [3] 0 0
Firenze
Country [4] 0 0
Italy
State/province [4] 0 0
Lecco
Country [5] 0 0
Italy
State/province [5] 0 0
Milano
Country [6] 0 0
Italy
State/province [6] 0 0
Milan
Country [7] 0 0
Italy
State/province [7] 0 0
Monza
Country [8] 0 0
Italy
State/province [8] 0 0
Napoli
Country [9] 0 0
Italy
State/province [9] 0 0
Potenza
Country [10] 0 0
Italy
State/province [10] 0 0
Pozzuoli
Country [11] 0 0
Italy
State/province [11] 0 0
Roma
Country [12] 0 0
Italy
State/province [12] 0 0
Rozzano
Country [13] 0 0
Italy
State/province [13] 0 0
Torino
Country [14] 0 0
Italy
State/province [14] 0 0
Treviglio
Country [15] 0 0
Italy
State/province [15] 0 0
Viagrande
Country [16] 0 0
Italy
State/province [16] 0 0
Vicenza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical, Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ipsen Recruitment Enquiries
Address 0 0
Country 0 0
Phone 0 0
See email
Fax 0 0
Email 0 0
clinical.trials@ipsen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
When will data be available (start and end dates)?
Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Available to whom?
Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05377684