Breast CancerNCT05404334
of Androgen Receptor Expression in Breast Cancer With or Without BRCA Mutation
An observational study of Breast Cancer, run by Banaras Hindu University at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Androgen receptor status and BRCA mutation
- How many people
- 231 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2021to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Adult, Older adult
Study population: Patients with breast cancer and benign breast diseases
Who may be able to join
- Histology proven cases of breast cancer
Who cannot join
- Patients with prior treatment
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Androgen receptor status and BRCA mutation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen receptor status and BRCA mutationDiagnostic test
Androgen receptor status by IHC and germ line BRCA mutation
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Patients with histologically proven breast cancer Receives: Diagnostic Test: Androgen receptor status and BRCA mutation | |
| Benign breast disease | Patients with benign breast diseases undergoing surgical resection Receives: Diagnostic Test: Androgen receptor status and BRCA mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptor expression
Androgen receptor expression and its correlation with molecular subtypes of breast cancer
Measured: 6 months
BRCA1 and BRCA2 mutations
BRCA mutations and its correlation with molecular subtypes of breast cancer
Measured: 6 months
Secondary outcomes (1)
AR and BRCA
Correlation of Androgen receptor expression with BRCA mutation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoj Pandey, Banaras Hindu University
- Investigators
- Manoj Pandey, MS, PhD, Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404334
- Sponsor's protocol ID
- BRAR1
- Status last verified
- Aug 2024
- First submitted
- 31 May 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Publications
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.
PubMed 28785183Vidula 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.
PubMed 31840050Zhang 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.
PubMed 25695063
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico-pathological Study of Androgen Receptor Expression in Breast Cancer With or Without BRCA Mutation
- ClinicalTrials.gov ID
- NCT05404334
- Acronym / sponsor ID
- BRAR1
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Diagnostic Test: Androgen receptor status and BRCA mutationPatients with histologically proven breast cancer |
| Benign breast disease | – | Diagnostic Test: Androgen receptor status and BRCA mutationPatients with benign breast diseases undergoing surgical resection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer and benign breast diseases
Key inclusion criteria (1 listed)
- Histology proven cases of breast cancer
Key exclusion criteria (2 listed)
- Patients with prior treatment
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen receptor status and BRCA mutationAndrogen receptor status by IHC and germ line BRCA mutation | Diagnostic test | Benign breast disease, Breast Cancer |
Primary outcome
Receptor expression
Time frame: 6 months
Androgen receptor expression and its correlation with molecular subtypes of breast cancer
BRCA1 and BRCA2 mutations
Time frame: 6 months
BRCA mutations and its correlation with molecular subtypes of breast cancer
1 secondary outcome
AR and BRCA
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 28785183Anand 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.
- Background: PubMed 31840050Vidula 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.
- Background: PubMed 25695063Zhang 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.
- Individual participant dataSharing planned: Yes. On request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Pandey, MS, PhD principal investigator
Banaras Hindu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Banaras Hindu University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receptor expression (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404334, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.