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New study tracks life quality in young breast cancer patients

NCT ID NCT05377684

Knowledge-focused Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study follows 450 premenopausal women with early-stage hormone-positive breast cancer in Italy. Researchers want to see how adding triptorelin to standard hormone therapy affects quality of life and hormone levels. The goal is to better understand the real-world impact of treatment, not to test a new cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

450 people

The number who actually took part.

Started

Jun 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early-stage breast cancer

Contacts and locations

Locations

  • AORN Cardarelli

    Naples, 80131, Italy

  • ASST BG OVEST Ospedale di Treviglio

    Treviglio, 24047, Italy

  • ASST Lecco

    Lecco, 23900, Italy

  • Azienda Ospedaliero-Universitaria Careggi (AOUC)

    Florence, 50134, Italy

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Italy

  • Humanitas Cancer Center

    Rozzano, Italy

  • IRCCS San Raffaele

    Milan, 20132, Italy

  • Istituto Europeo di Oncologia

    Milan, 20132, Italy

  • Istituto Nazionale Tumori

    Milan, 20133, Italy

  • Istituto Nazionale Tumori - Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Oncologico del Mediterraneo (IOM)

    Viagrande, 95029, Italy

  • Ospedale "S. Bortolo"

    Vicenza, 36100, Italy

  • Ospedale G. Battista - Molinette

    Torino, Italy

  • Ospedale Oncologico "A. Businco"

    Cagliari, 9121, Italy

  • Ospedale S. Gerardo

    Monza, Italy

  • Ospedale San Carlo

    Potenza, 85100, Italy

  • Ospedale Santa Maria delle Grazie

    Pozzuoli, 80078, Italy

  • P.O. Ospedale del Mare

    Naples, 80147, Italy

  • Policlinico S. Orsola - Malpighi

    Bologna, 40138, Italy

  • Policlinico Universitario A. Gemelli (Site A)

    Roma, 168, Italy

  • Policlinico Universitario A. Gemelli (Site B)

    Roma, 168, Italy

  • Università della Campania "L. Vanvitelli"

    Naples, 80138, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.