NCT03111615

HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Centro Hospitalar Lisboa Ocidental · Other Government
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hormone Dependent Neoplasms
• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	Aromatase Inhibitors	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

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-05-01
• Completion: 2020-05-01
• First posted: 2017-04-13
• Last updated: 2017-12-05

Locations

1 site across 1 country: Portugal