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

NCT05404334 | Completed DMC

• 1 other identifier: BRAR1
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Receptor expression

  Androgen receptor expression and its correlation with molecular subtypes of breast cancer

  6 months

• BRCA1 and BRCA2 mutations

  BRCA mutations and its correlation with molecular subtypes of breast cancer

  6 months

Secondary Outcomes (1)

• AR and BRCA

  6 months

Study Arms (2)

Breast Cancer

Patients with histologically proven breast cancer

Diagnostic Test: Androgen receptor status and BRCA mutation

Benign breast disease

Patients with benign breast diseases undergoing surgical resection

Diagnostic Test: Androgen receptor status and BRCA mutation

Interventions

Androgen receptor status and BRCA mutation DIAGNOSTIC_TEST

Androgen receptor status by IHC and germ line BRCA mutation

Benign breast disease; Breast Cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Female breast cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer and benign breast diseases

You may qualify if:

• Histology proven cases of breast cancer

You may not qualify if:

• Patients with prior treatment
• Pregnant and lactating women

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (3)

• Anand A, Singh KR, Kumar S, Husain N, Kushwaha JK, Sonkar AA. Androgen Receptor Expression in an Indian Breast Cancer Cohort with Relation to Molecular Subtypes and Response to Neoadjuvant Chemotherapy - a Prospective Clinical Study. Breast Care (Basel). 2017 Jul;12(3):160-164. doi: 10.1159/000458433. Epub 2017 Jun 16.

  PMID: 28785183 BACKGROUND

• Vidula N, Yau C, Wolf D, Rugo HS. Androgen receptor gene expression in primary breast cancer. NPJ Breast Cancer. 2019 Dec 10;5:47. doi: 10.1038/s41523-019-0142-6. eCollection 2019.

  PMID: 31840050 BACKGROUND

• Zhang L, Fang C, Xu X, Li A, Cai Q, Long X. Androgen receptor, EGFR, and BRCA1 as biomarkers in triple-negative breast cancer: a meta-analysis. Biomed Res Int. 2015;2015:357485. doi: 10.1155/2015/357485. Epub 2015 Jan 28.

  PMID: 25695063 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embedded blocks containing tumor and DNA will be retained

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Manoj Pandey, MS, PhD

  Banaras Hindu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months
• Access Criteria: on request

Locations

IN (1)