HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

Breast Cancer Female Clinical Trial

— HOTBreast  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03111615
• Other study ID #: CentroHLOBreastUnit
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 23, 2017
• Last updated: December 2, 2017
• Start date: May 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: December 2017
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: Vasco Fonseca, MD
• Phone: 0035121 043 1000
• Email: medicinavf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Hormone Dependent Neoplasms
• Neoplasms, Hormone-Dependent

Intervention

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

Locations

Country	Name	City	State
Portugal	Hospital São Francisco Xavier	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical outome	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	3 days 1 month and 3 months
Primary	Tumor Biology	Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values	6 weeks
Secondary	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	6 weeks
Secondary	Disease free survival	Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up	1 5 and 10 years
Secondary	Hormone treatment	Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up	1 5 and 10 years