HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer
NCT ID: NCT03111615
Last Updated: 2017-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2018-05-01
2020-05-01
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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
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))
No interventions assigned to this group
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
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
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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* \<50 y.o.
* Pre-menopausal state
50 Years
FEMALE
No
Sponsors
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Centro Hospitalar Lisboa Ocidental
OTHER_GOV
Responsible Party
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Zacharoula Sidiropoulou
Principal investigator
Principal Investigators
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Vasco Fonseca, MD
Role: PRINCIPAL_INVESTIGATOR
CHLO Medical Oncology dpt
Zacharoula Sidiropoulou
Role: PRINCIPAL_INVESTIGATOR
CHLO Surgery dpt
Locations
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Hospital São Francisco Xavier
Lisbon, , Portugal
Countries
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Central Contacts
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Other Identifiers
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CentroHLOBreastUnit
Identifier Type: -
Identifier Source: org_study_id