Mono-centric, observational, prospective study, designed for pts with diagnosis of hormone-positive breast cancer to evaluate the correlation between the response to hormonal treatment indicated by the reduction of the level of Ki67 and miRNA100 in two groups of patients
The potential role of miRNAs will be studied as a predictor of hormone sensitivity in hormone-positive breast carcinomas. The miRNA100 obtained on biopsy will be compared with the expression levels of those obtained from the surgically removed tumor, in order to assess the possible modulation of miRNA100 following hormonal treatment.
Study Type
OBSERVATIONAL
Enrollment
180
miRNA extraction
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, Italy
RECRUITINGEvaluation of the efficacy
the natural logarithm value of Ki67 \<1.0 defines the proliferative response to treatment. Response evaluation will be performed by measuring the reduction of Ki67 as a result of hormonal treatment according to a schedule defined on the basis of the stage of disease: patients with immediate operable cancer will be valued at the time of surgery (about 3 weeks). candidate patients to neoadjuvant hormone therapy and patients with stage 4 debut in hormonal therapy in advanced therapy (evaluation during the third week of starting treatment)
Time frame: 42 months or until disease progression
Evaluation of Tolerability
The frequency and severity of adverse events will be evaluated based on the NCI-CTCAE v 4.0 criteria
Time frame: 42 months or until disease progression
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