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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03111615
Recruitment Status : Unknown
Verified December 2017 by Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental

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.


Condition or disease Intervention/treatment Phase
Hormone Dependent Neoplasms Breast Cancer Female Drug: Aromatase Inhibitors Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aromatase Inhibitor group
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.
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

Other Name: Aromatase Inhibitor

No Intervention: Control group
Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg))
Aromatase Inhibitor Active surveillance
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
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

Other Name: Aromatase Inhibitor

Aromatase Inhibitor Active surveillance + aas
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
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

Other Name: Aromatase Inhibitor




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Other Outcome Measures:
  1. Surgical outome [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female sex
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111615


Contacts
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Contact: Vasco Fonseca, MD 0035121 043 1000 medicinavf@yahoo.com

Locations
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Portugal
Hospital São Francisco Xavier
Lisbon, Portugal
Sub-Investigator: Margarida Brito, MD         
Sponsors and Collaborators
Centro Hospitalar Lisboa Ocidental
Investigators
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Principal Investigator: Vasco Fonseca, MD CHLO Medical Oncology dpt
Principal Investigator: Zacharoula Sidiropoulou CHLO Surgery dpt
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Responsible Party: Zacharoula Sidiropoulou, Principal investigator, Centro Hospitalar Lisboa Ocidental
ClinicalTrials.gov Identifier: NCT03111615    
Other Study ID Numbers: CentroHLOBreastUnit
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental:
Aromatase inhibitors
Luminal Breast Cancer neoadjuvant hormone therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms, Hormone-Dependent
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs