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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404334
• Other study ID #: BRAR1
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Banaras Hindu University
• Contact: Manoj Pandey, MS, PhD
• Email: mpandey66[@]bhu.ac.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Histology proven cases of breast cancer

Exclusion Criteria:

• Patients with prior treatment

• Pregnant and lactating women

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Androgen receptor status and BRCA mutation
Androgen receptor status by IHC and germ line BRCA mutation

Locations

Country	Name	City	State
India	Banaras Hindu University	Varanasi	UP

Sponsors (1)

Lead Sponsor	Collaborator
Banaras Hindu University

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receptor expression	Androgen receptor expression and its correlation with molecular subtypes of breast cancer	6 months
Primary	BRCA1 and BRCA2 mutations	BRCA mutations and its correlation with molecular subtypes of breast cancer	6 months
Secondary	AR and BRCA	Correlation of Androgen receptor expression with BRCA mutation	6 months