Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cance… (NCT05377684) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
Italy450 participantsStarted 2022-06-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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…
What they're measuring
1
Proportion of participants reaching a clinically significant change in the global Quality of Life (QoL) score.