Post-menopausal women with localized luminal A breast cancer and considered at low risk of metastatic relapse MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 23.0 Level: LLT Classification code 10083237 Term: Luminal A breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: letrozole
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LETROZOLE
CAS Number: 112809-51-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Postmenopausal women: Postmenopausal status is defined by any of the following: - Prior bilateral oophorectomy - Age =60 years - Age >50 and +0.355 10.Patients eligible to receive or have recently started (with a maximum of 4 months of adjuvant hormone therapy prior to enrollment) an adjuvant hormone therapy (letrozole, anastrozole, or exemestane) 11.Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures 12.Patients must be affiliated to a Social Security System (or equivalent) 13.Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 556
Exclusion criteria
Exclusion criteria: 1.Patients who received a neo-adjuvant hormone therapy (only 4 months prior to enrollment will be allowed), a neo-adjuvant or adjuvant chemotherapy or preoperative medical treatment 2.Any local or regional recurrence or metastatic disease 3.Non-invasive carcinoma 4.Bilateral breast cancer (except in case of contralateral DCIS), or history of other invasive ipsi- or contralateral breast cancer 5.Patients with a history of another malignancy except for properly treated cervical carcinoma in situ and non-melanoma cancer of the skin 6.Women with high-risk breast cancer predisposing deleterious germline mutations 7.Contra-indications to the administration of anti-aromatase inhibitors 8.Patients enrolled in another therapeutic study within 30 days of inclusion 9.Patients with any other disease or illness, which requires hospitalization or is incompatible with the trial treatment 10.Patients unwilling or unable to comply with trial obligations for geographic, social, physical or psychological reasons, or who are unable to understand the purpose and procedures of the trial 11.Persons deprived of their liberty or under protective custody or guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively demonstrate that an adjuvant aromatase inhibitor therapy duration limited to 2 years is associated with high distant metastasis-free survival at 5 years in a selected population with invasive breast cancer at low risk of metastatic recurrence;Secondary Objective: •Evaluate Invasive Disease-Free Survival (iDFS) •Evaluate Invasive breast cancer-free survival (iBCFS) •Evaluate breast cancer specific survival (BCSS) •Evaluate overall survival (OS) •Assess quality of life (QoL) at baseline and every year until 5 years after the start of the study in term of general QoL, fatigue, psychological, and cognitive functions •Compare the survival and QoL endpoints with the breast cancer patients in the CANTO cohort who took 5 years of hormonal treatment •Evaluate the safety of the treatment in the study population;Primary end point(s): Distant metastasis–free survival (DMFS) defined as the time from date of registration to date of first event of distant recurrence, death, or second primary non-breast invasive cancer;Timepoint(s) of evaluation of this end point: see above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Invasive disease free survival (iDFS): defined as duration of time from date of registration until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast cancer recurrence), invasive contralateral breast cancer, second primary non breast invasive cancer (excluding non-melanoma skin cancer), or death from any cause. Invasive breast cancer–free survival (iBCFS) is similar to iDFS but excluding second primary non breast invasive cancers. •Breast cancer specific survival (BCSS): defined as the time from registration to death from breast cancer; or censored at date the person was last known alive. •Overall survival (OS): defined as the time from date of registration to date of death due to any cause •Quality of life will be assessed at baseline and every year up to five years post study entry using the following questionnaires: oEORTC QLQC30 , an integrated system for the evaluation of health-related Qol of cancer patients, employed in over 2,000 cancer clinical trials and extensively validated, which includes functional scales for physical, role, cognitive, emotional, and social functioning, symptom scales for fatigue, pain, and nausea/vomiting, and single items for dyspnea, appetite loss, insomnia, constipation and diarrhea. oThe breast cancer specific companion modules EORTC QLQ-BR23/QLQ-BR45 used in conjunction with the EORTC QLQ-C30, are valid and reliable in breast cancer specific Qol assessment, including body image and systemic therapy side effects. The QLQ-BR-23 was updated and 22 new questions were added to provide a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients’QoL. o The fatigue subscale EORTC QLQ-F12, including emotional, cognitive and physical fatigue subscales. o Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) (14-item scale (7 items for depression and 7 for anxiety) that has been | — |
Countries
France
Contacts
Public ContactClinical Project Manager
UNICANCER
Outcome results
None listed