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The number of mutation of genes BRCA1 and BRCA2 in Indian Breast Cancer Patients

Prevalence of BRCA1 and BRCA2 Mutation Among Indian Breast Cancer Patients: A Multicentre Cross-Sectional Study BRCA Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/06/043293
Enrollment
313
Registered
2022-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

None listed

Sponsors

AstraZeneca Pharma India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are ready to provide written informed consent 2. Patients of both genders of > 18 years of age 3. Newly diagnosed breast cancer patients who may or may not have undergone primary surgery with or without radiotherapy, and who have not yet completed their first line of systemic therapy. First line therapy is defined as neo(adjuvant) chemotherapy/ hormonal therapy/HER2 targeted therapy.

Exclusion criteria

Exclusion criteria: 1. Patients with breast cancer with HER2 IHC 2+, in whom in situ hybridization (ISH) is not done or not planned to be done. 2. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study.

Design outcomes

Primary

MeasureTime frame
The proportion of newly diagnosed breast cancer patients with pathogenic or likely pathogenic BRCA1 or BRCA 2 mutationsTimepoint: Single visit

Secondary

MeasureTime frame
To determine the percentage of pathogenic/likely pathogenic germline BRCA1 mutation in comparison to pathogenic/likely pathogenic germlineBRCA2 mutation in Indian population.Timepoint: Single visit

Countries

India

Contacts

Public ContactAmit Kumar

AstraZeneca Pharma India Ltd

kirtan.bhatt@astrazeneca.com9886266442

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026