Clinical Trial: HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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".

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

Sponsor: Centro Hospitalar Lisboa Ocidental

Current Primary Outcome: Tumor Biology [ Time Frame: 6 weeks ]

Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tumor Pathology response [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 5 and 10 years ]
    Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up


Original Secondary Outcome: Same as current

Information By: Centro Hospitalar Lisboa Ocidental

Dates:
Date Received: February 23, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2019
Last Updated: April 21, 2017
Last Verified: April 2017