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To find out how the latest drugs will Help Breast and Ovarian Cancer Patients in Eastern India with Gene Problems.

Outcomes of Breast and Ovarian cancer patients with HRD/BRCA gene alterations treated with PARP inhibitors at a tertiary care hospital in Eastern India. - BROCA-PI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/059748
Enrollment
340
Registered
2023-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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 Health Condition 2: C569- Malignant neoplasm of unspecifiedovary

Interventions

Control Intervention1: NIL: NIL

Sponsors

INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed Breast and ovarian cancer patients greater than 18 years with HRD/BRCA gene alterations registered in the department of Medical Oncology, IMS and SUM hospital

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years of age 2. Patients not meeting the above-mentioned criteria 3. Patients or patient relatives who do not consent to the testing 4. Patients with BRCA1 and/or BRCA2 mutations that are considered to be non-detrimental (eg, “Variants of uncertain clinical significance ? or “Variant of unknown significance ? or “Variant, favor polymorphism ? or “benign polymorphism, ? etc).

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)Timepoint: 2 years

Secondary

MeasureTime frame
1. To determine Overall survival among HRD/ BRCA positive Breast and ovary patients taking PARP inhibitors (Olaparib/Rucaparib). 2. To determine Safety, Efficacy among HRD/ BRCA positive Breast and ovary patients taking PARP inhibitors (Olaparib/Rucaparib). 3. To determine the prevalence of BRCA/ HRD positive mutations among breast and ovarian cancer patients 4. Identifying the clinical and pathological profile of the patients testing positive for HRD/ g BRCA/t BRCA mutations. 5. To find out the hindrances in doing HRD/ g BRCA/ t BRCA mutation testing and in obtaining PARP inhibitors (Olaparib/Rucaparib). Timepoint: 3years,5years

Countries

India

Contacts

Public ContactSoumya Surath Panda

Institute of Medical Sciences and SUM Hospital

drgbiswas@gmail.com9937500878

Outcome results

None listed

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