Hormone Dependent Neoplasms, Breast Cancer Female
Conditions
Keywords
Aromatase inhibitors, Luminal Breast Cancer neoadjuvant hormone therapy
Brief summary
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.
Detailed description
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
Interventions
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
Sponsors
Centro Hospitalar Lisboa Ocidental
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Menopausal woman of equal or above 50 y.o. with breast biopsy of Luminal like breast carcinoma
Exclusion criteria
* informed consent * \<50 y.o. * Pre-menopausal state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Biology | 6 weeks | Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Pathology response | 6 weeks | 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 |
| Disease free survival | 1 5 and 10 years | Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up |
| Hormone treatment | 1 5 and 10 years | Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgical outome | 3 days 1 month and 3 months | Eventual influence of the aromatase inibitor in the surgical procedure (time, bleeding, scaring, infections, seroma formation, sentinel node detection and axillary response) is to be evaluated |
Countries
Portugal
Contacts
Primary ContactVasco Fonseca, MD
Outcome results
None listed