Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates. Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy. Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.
Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid. In this way, authors want to investigate if: 1. st This approach influences the tumor biology 2. nd This approach influences tumor pathologic response and progression free survival. 3. rd It is a valid approach and in which grade, for patients that refuse surgical treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement. Venlafaxin 75 mg is to be administrated cases indicated
Hospital São Francisco Xavier
Lisbon, Portugal
Tumor Biology
Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values
Time frame: 6 weeks
Tumor Pathology response
Effects of neoadjuvant aromatase inibitors on tumor pathologic response , in terms of breast imaging re-avaliation before surgical intervention. For patients that refuse surgery or extend hormone therapy for other reasons
Time frame: 6 weeks
Disease free survival
Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up
Time frame: 1 5 and 10 years
Hormone treatment
Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up
Time frame: 1 5 and 10 years
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