Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment

NCT05377684 | Active Not Recruiting

• 1 other identifier: CLIN-52014-452
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 22

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.

Conditions

Early-stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (16)

• Tumor characteristics.

  At baseline.

• Percentage of days covered of compliance

  At 18 months

• Description of breast cancer treatment.

  At baseline.

• Identification of potential demographic factors predictive of any treatment switch.

  At 18 months.

• Identification of demographic and tumor characteristics correlated to the entire prescribed breast cancer treatment.

  At 18 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (22)

Policlinico S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Ospedale Oncologico "A. Businco"

Cagliari, 9121, Italy

Location

Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, 50134, Italy

Location

ASST Lecco

Lecco, 23900, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

IRCCS San Raffaele

Milan, 20132, Italy

Location

Istituto Europeo di Oncologia

Milan, 20132, Italy

Location

Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Ospedale S. Gerardo

Monza, Italy

Location

AORN Cardarelli

Naples, 80131, Italy

Location

Istituto Nazionale Tumori - Fondazione Pascale

Naples, 80131, Italy

Location

Università della Campania "L. Vanvitelli"

Naples, 80138, Italy

Location

P.O. Ospedale del Mare

Naples, 80147, Italy

Location

Ospedale San Carlo

Potenza, 85100, Italy

Location

Ospedale Santa Maria delle Grazie

Pozzuoli, 80078, Italy

Location

Policlinico Universitario A. Gemelli (Site A)

Roma, 168, Italy

Location

Policlinico Universitario A. Gemelli (Site B)

Roma, 168, Italy

Location

Humanitas Cancer Center

Rozzano, Italy

Location

Ospedale G. Battista - Molinette

Torino, Italy

Location

ASST BG OVEST Ospedale di Treviglio

Treviglio, 24047, Italy

Location

Istituto Oncologico del Mediterraneo (IOM)

Viagrande, 95029, Italy

Location

Ospedale "S. Bortolo"

Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ipsen Medical, Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 17, 2022
• Study Start: June 9, 2022
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

IT (22)