Clinical trial NCT05377684: Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early-stage Breast Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility 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.

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

Primary outcomes:
measure: Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score.
timeFrame: At 18 months.
Secondary outcomes:
measure: Tumor characteristics.
timeFrame: At baseline.
measure: Percentage of days covered of compliance
timeFrame: At 18 months
measure: Description of breast cancer treatment.
timeFrame: At baseline.
measure: Identification of potential demographic factors predictive of any treatment switch.
timeFrame: At 18 months.
measure: Identification of demographic and tumor characteristics correlated to the entire prescribed breast cancer treatment.
timeFrame: At 18 months.
measure: Proportion of participants who switch between triptorelin formulations, from AI to TAM or vice-versa, or undergo both triptorelin and adjuvant therapy switches
timeFrame: At 18 months.
measure: Proportion of disease-free participants.
timeFrame: At 18 months.
measure: Proportion of participants alive.
timeFrame: At 18 months.
measure: Proportion of compliant patients (100% of the planned injections) to triptorelin
timeFrame: At 18 months.
measure: Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of suboptimal OFS.
timeFrame: At 18 months.
measure: Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of clinically significant global QoL change
timeFrame: At 6, 12 and 18 months.
measure: Incidence of all treatment-emergent adverse events (TEAEs)
timeFrame: From baseline up to 18 months.
measure: Change in the Quality of Life (QoL) score using the FACT-G questionnaire with the Endocrine Symptoms (ES) subscale.
timeFrame: From baseline and at 6, 12 and 18 months
measure: Description of demographic data.
timeFrame: At baseline.
measure: Description of demographic data
timeFrame: At baseline.
measure: Proportion of participants with hormonal levels (E1, E2 and FSH) corresponding to Ovarian Function Suppression (OFS)
timeFrame: From baseline up to 18 months.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi
city: Cagliari
country: Italy
facility: Ospedale Oncologico "A. Businco"
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi (AOUC)
city: Lecco
country: Italy
facility: ASST Lecco
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Monza
country: Italy
facility: Ospedale S. Gerardo
city: Napoli
country: Italy
facility: AORN Cardarelli
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - Fondazione Pascale
city: Napoli
country: Italy
facility: Università della Campania "L. Vanvitelli"
city: Napoli
country: Italy
facility: P.O. Ospedale del Mare
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria delle Grazie
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli (Site A)
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli (Site B)
city: Rozzano
country: Italy
facility: Humanitas Cancer Center
city: Torino
country: Italy
facility: Ospedale G. Battista - Molinette
city: Treviglio
country: Italy
facility: ASST BG OVEST Ospedale di Treviglio
city: Viagrande
country: Italy
facility: Istituto Oncologico del Mediterraneo (IOM)
city: Vicenza
country: Italy
facility: Ospedale "S. Bortolo"
Study officials:
affiliation: Ipsen
name: Ipsen Medical, Director
role: STUDY_DIRECTOR
References: