of Androgen Receptor Expression in Breast Cancer With or Without BRCA Mutation

August 9, 2024 updated by: Manoj Pandey, Banaras Hindu University

Clinico-pathological Study of Androgen Receptor Expression in Breast Cancer With or Without BRCA Mutation

Androgen Receptor is extensively expressed in BRCA and its role in the disease may differ depending upon molecular subtypes and stages. Androgen Receptor (AR) may act as an antagonist of estrogen receptor α (ERα), in ERα induced effect, whereas in the absence of estrogens, AR may act as an agonist, of ERα- promoting tumor. Thus, depending on the BRCA micro-environment, both agonists and antagonists of the AR have been suggested for therapeutic approaches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The rate of AR positivity in breast cancer is about 60% to 80%. Biologically the AR pathway has cross talk with several other key signaling pathway, including the PI3K/Akt/mTOR and MAPK Pathways, and with other receptor, including estrogen receptor and human epidermal growth factor receptor-2. In clinical trials in patients with breast cancer, AR targeted therapies such as AR agonists, AR antagonists, PARP inhibitors, and PI3K inhibitors have shown promising results. The use of AR targeted therapies in conjunction with other agent has been investigated for overcoming resistance to AR focused treatments. Thus, the value of AR positivity as a prognostic marker has not been identified. Several retrospective clinical studies have shown that AR might be a prognostic or predictive factor in breast cancer. BRCA1 mutation accounts for the progress of hereditary breast cancers and is in connection with unique clinicopathological characteristics compared with sporadic breast cancers. The database is still evolving and newer mutation and their significance is being found every day. Also, there were several limitations to these previous studies. First, the cut-off for AR positivity was arbitrary. In most of the studies, the cut-off points were 1% or 10% and weren't enough to predict carcinoma survival. Moreover, quite 90% of the studies were conducted in non-Asian regions. Most of the studies involving Asian patients studied the prognostic role of AR in TNBC patients, with inconclusive results. There are only a few studies from Indian continents and none has correlated the AR expression with BRCA.

After the written inform consent in case of fresh recruitment the blood will be collected and tissue blocks will be obtained, use of already available blocks of patients who earlier participated in another study is also proposed.

(a) Samples will be stored for DNA study and will be frozen in liquid nitrogen and stored at -80 °C until further processing.

(samples will store in 10% formalin at room temperature (RT) for Immunohistochemistry

Study Type

Observational

Enrollment (Actual)

231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • UP
      • Varanasi, UP, India, 221005
        • Banaras Hindu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with breast cancer and benign breast diseases

Description

Inclusion Criteria:

  • Histology proven cases of breast cancer

Exclusion Criteria:

  • Patients with prior treatment
  • Pregnant and lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer
Patients with histologically proven breast cancer
Diagnostic test: Androgen receptor status and BRCA mutation
Androgen receptor status by IHC and germ line BRCA mutation
Benign breast disease
Patients with benign breast diseases undergoing surgical resection
Diagnostic test: Androgen receptor status and BRCA mutation
Androgen receptor status by IHC and germ line BRCA mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receptor expression
Time Frame: 6 months
Androgen receptor expression and its correlation with molecular subtypes of breast cancer
6 months
BRCA1 and BRCA2 mutations
Time Frame: 6 months
BRCA mutations and its correlation with molecular subtypes of breast cancer
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AR and BRCA
Time Frame: 6 months
Correlation of Androgen receptor expression with BRCA mutation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banaras Hindu University

Investigators

  • Principal Investigator: Manoj Pandey, MS, PhD, Banaras Hindu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On request

IPD Sharing Time Frame

3 months

IPD Sharing Access Criteria

on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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