MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer

NCT01231386 | Completed DMC

• 1 other identifier: 09147
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation and renewal both under physiologically normal as well as in malignant conditions. Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum will allow for identification of miRNA markers of prognosis and as indicators and potential targets for personalized therapies. In this proposal, specimens from patients treated in the clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be applied to develop specific therapies.

Conditions

Breast Cancer

Keywords

Female Breast Cancer; miRNA expression; Neoadjuvant/Adjuvant Treatment; Locally and Inflammatory Breast Cancer

Outcome Measures

Primary Outcomes (7)

• Performance of miRNA profiling from tumor samples from primary breast tumors

  3 years after completion of sample collection

• Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points

  3 years after completion of sample collection

• Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum

  3 years after competion of sample collection

• Correlation of classic tumor markers such as estrogen and progesterone receptor (ER,PR), and HER2 expression with tumor stage and grade

  3 years after completion of sample collection

• Determination of specific miRNA functions

  3 years after completion of sample collection

• Determination of ability to knock down functionally relevant overexpressed miRNAs by miR-sponge/antagomirs

  3 years after completion of sample collection

• Design of prospective pilot phase I-II trials to interfere with dysfunctional/dysregulated miRNA expression

  3 years after completion of sample collection

Eligibility Criteria

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

Study Population

Female, Breast Cancer, \> 18 years, regardless of histology, treatment phase, or stage. However, only patients with Stage II-III disease from IRB #05015 will be accrued, in order to assure that sufficient tumor tissue will be available.

You may qualify if:

• Female,
• Breast Cancer
• \> 18 years,
• regardless of histology, treatment phase, or stage

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and Blood Procurement. Breast cancer tissues from core biopsies (as available, preferably fresh frozen or RNA-later preserved, but in case of lack of availability, formalin-fixed paraffin-embedded \[FFPE\] core or tissue samples) which have been collected or will be collected under IRB#05091 or 05015.

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• George Somlo, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 1, 2010
• Study Start: November 1, 2009
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

US (1)