Prospective Observational Study of Antitumor Activity Correlation Between Hormonal Therapy and Expression miRNA100

Breast Cancer Clinical Trial

— BC-P1-2013  

Official title:

Prospective Observational Study to Evaluate the Correlation Between Antitumor Activity of Hormone Therapy and the Expression of Micro-RNA (miRNA) 100

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02950207
• Other study ID #: BC-P1-2013
• Status: Recruiting
• Phase: N/A
• First received: October 20, 2016
• Last updated: November 2, 2016
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: October 2016
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Annamaria Nuzzo, PhD
• Phone: +390119933398
• Email: annamaria.nuzzo[@]ircc.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent

• 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:

• Previous treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Genetic:
• miRNA
miRNA extraction

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo	Candiolo	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation 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)	42 months or until disease progression	No
Secondary	Evaluation of Tolerability	The frequency and severity of adverse events will be evaluated based on the NCI-CTCAE v 4.0 criteria	42 months or until disease progression	No