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HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer (HOTBreast)

Primary Purpose

Hormone Dependent Neoplasms, Breast Cancer Female

Status
Unknown status
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Aromatase Inhibitors
Sponsored by
Centro Hospitalar Lisboa Ocidental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Dependent Neoplasms focused on measuring Aromatase inhibitors, Luminal Breast Cancer neoadjuvant hormone therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital São Francisco Xavier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Other

Other

Arm Label

Aromatase Inhibitor group

Control group

Aromatase Inhibitor Active surveillance

Aromatase Inhibitor Active surveillance + aas

Arm Description

Female patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery.

Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg))

Female patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht

emale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Disease free survival
Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up
Hormone treatment
Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up

Full Information

First Posted
February 23, 2017
Last Updated
December 2, 2017
Sponsor
Centro Hospitalar Lisboa Ocidental
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1. Study Identification

Unique Protocol Identification Number
NCT03111615
Brief Title
HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer
Acronym
HOTBreast
Official Title
Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar Lisboa Ocidental

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: st This approach influences the tumor biology nd This approach influences tumor pathologic response and progression free survival. rd It is a valid approach and in which grade, for patients that refuse surgical treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Dependent Neoplasms, Breast Cancer Female
Keywords
Aromatase inhibitors, Luminal Breast Cancer neoadjuvant hormone therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aromatase Inhibitor group
Arm Type
Experimental
Arm Description
Female patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg))
Arm Title
Aromatase Inhibitor Active surveillance
Arm Type
Other
Arm Description
Female patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht
Arm Title
Aromatase Inhibitor Active surveillance + aas
Arm Type
Other
Arm Description
emale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht
Intervention Type
Drug
Intervention Name(s)
Aromatase Inhibitors
Other Intervention Name(s)
Aromatase Inhibitor
Intervention Description
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
Primary Outcome Measure Information:
Title
Tumor Biology
Description
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
Secondary Outcome Measure Information:
Title
Tumor Pathology response
Description
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
Title
Disease free survival
Description
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
Title
Hormone treatment
Description
Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up
Time Frame
1 5 and 10 years
Other Pre-specified Outcome Measures:
Title
Surgical outome
Description
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
Time Frame
3 days 1 month and 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female sex
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vasco Fonseca, MD
Phone
0035121 043 1000
Email
medicinavf@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasco Fonseca, MD
Organizational Affiliation
CHLO Medical Oncology dpt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zacharoula Sidiropoulou
Organizational Affiliation
CHLO Surgery dpt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital São Francisco Xavier
City
Lisbon
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarida Brito, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer

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