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

NCT02950207 | Unknown

• 1 other identifier: BC-P1-2013
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of Tolerability

  42 months or until disease progression

Interventions

miRNA GENETIC

miRNA extraction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

post menopausal hormone-positive breast cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, 10060, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MicroRNAs

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RNA, Antisense; Antisense Elements (Genetics); Nucleic Acids, Nucleotides, and Nucleosides; RNA; Nucleic Acids; RNA, Small Untranslated; RNA, Untranslated

Study Officials

• Filippo Montemurro, MD

  FPO-IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Nuzzo, PhD

CONTACT

+390119933398; annamaria.nuzzo@ircc.it

Filippo Montemurro, MD

CONTACT

filippo.montemurro@ircc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: November 1, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 3, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)