Early-stage Breast CancerROSENCT05377684
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
An observational study of Early-stage Breast Cancer, run by Ipsen at 22 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer
- How many people
- 450 participants
- Where
- 22 sitesItaly
- Study dates
- 9 Jun 2022to 4 Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Italy22 sites
Policlinico S. Orsola - Malpighi
Bologna, 40138
Ospedale Oncologico "A. Businco"
Cagliari, 9121
Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, 50134
ASST Lecco
Lecco, 23900
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
IRCCS San Raffaele
Milan, 20132
Istituto Europeo di Oncologia
Milan, 20132
Istituto Nazionale Tumori
Milan, 20133
Ospedale S. Gerardo
Monza
AORN Cardarelli
Naples, 80131
Istituto Nazionale Tumori - Fondazione Pascale
Naples, 80131
Università della Campania "L. Vanvitelli"
Naples, 80138
P.O. Ospedale del Mare
Naples, 80147
Ospedale San Carlo
Potenza, 85100
Ospedale Santa Maria delle Grazie
Pozzuoli, 80078
Policlinico Universitario A. Gemelli (Site A)
Roma, 168
Policlinico Universitario A. Gemelli (Site B)
Roma, 168
Humanitas Cancer Center
Rozzano
Ospedale G. Battista - Molinette
Torino
ASST BG OVEST Ospedale di Treviglio
Treviglio, 24047
Istituto Oncologico del Mediterraneo (IOM)
Viagrande, 95029
Ospedale "S. Bortolo"
Vicenza, 36100
About this study
Official 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
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.
- Conditions
- Early-stage Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 18 months.
Secondary outcomes (16)
Tumor characteristics.
Measured: At baseline.
Percentage of days covered of compliance
Measured: At 18 months
Description of breast cancer treatment.
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))
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 18 months.
Proportion of compliant patients (100% of the planned injections) to triptorelin
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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);
Measured: At baseline.
Description of demographic data
Including Body Mass Index calculation
Measured: 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)
Measured: From baseline up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start9 Jun 2022
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical, Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377684
- Sponsor's protocol ID
- CLIN-52014-452
- Acronym
- ROSE
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.