Current partner codePEPTIDESDE
NCT05377684·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

450

Locations

22

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    May 17, 2022

  2. Study start

    Jun 9, 2022

  3. Primary completion

    Jun 4, 2026

  4. Study completion

    Jun 4, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 10, 2026

Outcomes

What the study measures.

Primary outcomes

Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score.

Time frame · At 18 months.

Defined as a minimum change of ≥4 points using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire.

Secondary outcomes

Tumor characteristics.

Time frame · At baseline.

Percentage of days covered of compliance

Time frame · At 18 months

Description of breast cancer treatment.

Time frame · At baseline.

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))

Identification of potential demographic factors predictive of any treatment switch.

Time frame · At 18 months.

A multivariate logistic regression will be used to identify demographic factors predictive of any treatment switches.

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

Time frame · At 18 months.

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.

Proportion of participants who switch between triptorelin formulations, from AI to TAM or vice-versa, or undergo both triptorelin and adjuvant therapy switches

Time frame · At 18 months.

The switches between triptorelin formulation or from the AI to TAM will be described together with the reasons for switches.

Proportion of disease-free participants.

Time frame · At 18 months.

Disease-free survival is defined as the time from triptorelin initiation to disease recurrence as determined by the Investigator.

Proportion of participants alive.

Time frame · At 18 months.

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.

Proportion of compliant patients (100% of the planned injections) to triptorelin

Time frame · At 18 months.

Identification of potential demographic, tumor-related or breast cancer treatment-related factors predictive of suboptimal OFS.

Time frame · At 18 months.

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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

Study locations

22 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

Policlinico S. Orsola - Malpighi

Bologna, Italy

Ospedale Oncologico "A. Businco"

Cagliari, Italy

Azienda Ospedaliero-Universitaria Careggi (AOUC)

Florence, Italy

ASST Lecco

Lecco, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS San Raffaele

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori

Milan, Italy

Ospedale S. Gerardo

Monza, Italy

AORN Cardarelli

Naples, Italy

Istituto Nazionale Tumori - Fondazione Pascale

Naples, Italy

Università della Campania "L. Vanvitelli"

Naples, Italy

P.O. Ospedale del Mare

Naples, Italy

Ospedale San Carlo

Potenza, Italy

Ospedale Santa Maria delle Grazie

Pozzuoli, Italy

Policlinico Universitario A. Gemelli (Site A)

Roma, Italy

Policlinico Universitario A. Gemelli (Site B)

Roma, Italy

Humanitas Cancer Center

Rozzano, Italy

Ospedale G. Battista - Molinette

Torino, Italy

ASST BG OVEST Ospedale di Treviglio

Treviglio, Italy

Istituto Oncologico del Mediterraneo (IOM)

Viagrande, Italy

Ospedale "S. Bortolo"

Vicenza, Italy

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Triptorelin.

Related PeptideStat pages

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