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Retrospective data collection and analysis of patients who had received Talzopari drug

Retrospective observational study of safety and efficacy of Talazoparib in BRCA1/2 or PALB2 mutation breast cancer. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/10/076008
Enrollment
6
Registered
2024-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Intervention1: Nil: NA Control Intervention1: Nil: NA

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients who were included in Talazoparib patient access program. To be enrolled in the program, patients were required to have fulfilling the following criteria. - Patients with age 18 years or older with any gender and diagnosed with a deleterious, suspected deleterious, or pathogenic germline BRCA1/2 or PALB2 mutation breast will be included in the analysis. - At least 1 EMR record of followup, post initiation of study treatment.

Exclusion criteria

Exclusion criteria: 1. No available EMR records

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is to find the PFS of patients treated with talazoparib as a monotherapy.Timepoint: 1 year—

Secondary

MeasureTime frame
The secondary objectives of the study are to evaluate the following: 1. Objective response rate (ORR) 2. Overall survival (OS) 3. Safety of talazoparib The exploratory objectives are to evaluate the duration of response (DOR) for objective responders.Timepoint: 1 year—

Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Center

sudeepgupta04@yahoo.com02224177201

Outcome results

None listed

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