Prospective Observational Study of Antitumor Activity Correlation Between Hormonal Therapy and Expression miRNA100
NCT ID: NCT02950207
Last Updated: 2016-11-03
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
180 participants
OBSERVATIONAL
2014-01-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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miRNA
miRNA extraction
Eligibility Criteria
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Inclusion Criteria
* Age greater than 18 years
* histological diagnosis of invasive carcinoma of the breast
* X-ray evidence (mammography and / or ultrasound) strongly suggestive for the presence of invasive breast cancer (BIRADS 4c or BIRADS 5) of greater than 15mm diameter.
* Carcinoma stage I (if diameter\> 15 mm) or II, unresectable, or
* Carcinoma in stage II or III, operable as a result of presurgical therapy, or
* Carcinoma in IV debut stage, asymptomatic, with primary operable breast cancer, or as a result of presurgical therapy
* Positivity for the estrogen receptor and / or to the progestin defined as the expression of one or both hormone receptors in ≥10% of tumor cells
* Negativity for HER2
* Cell proliferation, defined as the percentage of Ki67 positive tumor cells,\> 5% (corresponding to a value of 1.79 after log-normal transformation)
* Postmenopausal status
* Ability to take an oral therapy, in the absence of malabsorption syndrome known, previous stomach surgery or the small intestine
* Ability to perform the staging examinations and screening provided for in the
* Protocol
* Eastern Cooperative Oncology Group (ECOG) = 0
* The patients will have a normal bone marrow function, liver and kidney
Exclusion Criteria
* Other cancers diagnosed in the last five years, with the exception of basal cell or squamous cell carcinoma of the skin, melanoma in situ or cervical cancer in situ.
* Premenopausal
* Known hypersensitivity to letrozole or to any of its excipients (for example: women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or mal absorption of glucose / galactose).
* Evidence of a severe and poorly controlled systemic disease affecting the lung, heart, liver, kidney that may compromise adherence to treatment or an extended follow-up.
* Inflammatory bowel disease not controlled (eg Crohn's disease, ulcerative colitis).
* Active infection and / or inadequately controlled.
* Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
* Breast cancer triple negative, or negative for both HER2 overexpression for the expression of hormone receptors.
18 Years
FEMALE
No
Sponsors
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Fondazione del Piemonte per l'Oncologia
OTHER
Responsible Party
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Principal Investigators
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Filippo Montemurro, MD
Role: PRINCIPAL_INVESTIGATOR
FPO-IRCCS
Locations
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Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, Italy
Countries
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Central Contacts
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Facility Contacts
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Annamaria Nuzzo, PhD
Role: primary
Other Identifiers
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BC-P1-2013
Identifier Type: -
Identifier Source: org_study_id