C509 Breast, unspecified Breast, unspecified
Conditions
Interventions
None listed
Sponsors
ABBOTT LABORATORIOS S.A.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Patients must be postmenopausal, according to any of the following criteria, given that letrozole is ineffective in pre- or perimenopausal patients, and may stimulate ovarian function, confirmation of postmenopausal status is required. • Patients of any age who have undergone bilateral oophorectomy (including castration for radiotherapy and amenorrhea for> 3 months) • Patients 56 years of age or older. If the patient presents any evidence of ovarian function, biochemical evidence of definitive postmenopausal status (defined as postmenopausal levels of estradiol, LH and FSH) is required. • Patients 55 years of age or younger should have biochemical evidence of a definitive postmenopausal status (defined as postmenopausal levels of estradiol, LH, and FSH). Patients who have received analogues of LHRH during the previous year are eligible if they meet the criteria described above for confirmation of postmenopausal status. • Patients must be accessible for follow-up • Characteristics of the disease • At the time of diagnosis, patients must have had a resectable, non-inflammatory breast cancer. • Patients must be clinically free of disease at the time of randomization. (Note: it is recommended, but it is not required that the disease-free status be verified through an abdominal ecotomography, chest X-ray and bone scintigraphy (in case of symptoms). Mammography is recommended within 1 year prior to randomization). • Patients must have had a tumor with positive steroidal hormone receptor (RE and / or RPg), determined by immunohistochemistry, after surgery and prior to the start of previous endocrine therapy. • After primary surgery, eligible patients must have had evidence of lymph node involvement, either in the axilla or in the internal mammary chain, but without supraclavicular involvement.
Exclusion criteria
Exclusion criteria: • There must not have been evidence of a recurrence of the disease or distant metastatic disease at any time prior to randomization. • Patients with bilateral breast cancer are not eligible. • Patients who have had a bone fracture secondary to osteoporosis at any time during the 4-6 years of hormone therapy with SERMs / AI are not eligible. • Patients with another previous or concomitant malignancy are not eligible, EXCEPT the following adequately treated: basal cell or squamous cell carcinoma of the skin, cervical or bladder carcinoma in situ, carcinoma in situ of contra-or ipsilateral breast. • Patients with non-malignant systemic comorbidity (cardiovascular, renal, pulmonary, etc.) who would avoid long-term follow-up are not eligible. • They are not eligible: patients with psychiatric disorders, addictive, or any disorder that interferes with the adherence of the patient to the indications of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is defined as the time from randomization to local recurrence (including limited recurrence to the breast after conservative treatment), regional or distant, contralateral breast cancer, appearance of a second primary tumor (non-breast) or death by any cause, any of the events occurs first. NAME OF THE RESULT: Disease-free survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After the study | — |
Secondary
| Measure | Time frame |
|---|---|
| It is defined as the time from randomization to local recurrence (including limited recurrence to the breast after conservative treatment), regional or distant, contralateral breast cancer, appearance of a second primary tumor (non-breast) or death by any cause, any of the events occurs first. NAME OF THE RESULT: Disease-free survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After the study;Defined as the time from randomization to death from any cause NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment;Defined as the time from randomization to systemic recurrence or distant metastatic disease (excluding the local scar / chest wall / skin of the mastectomy, the ipsilateral breast in the cases of conservative surgery, or ipsilateral armpit and ipsilateral internal mammary nodes), appearance of a second primary tumor (not breast), or death from any cause, whichever event occurs first. NAME OF THE RESULT: Systemic disease free survival (SLES) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment;Defined as the time from randomization to local recurrence (including recurrence in the breast after conservative surgery), regional or distant, or contralateral breast cancer. NAME OF THE RESULT: Breast cancer free interval PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment | — |
Countries
Peru
Outcome results
None listed