Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03286842
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2017-08-17
Brief Title:
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase IIIb Single-arm Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA12 Mutations
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label multi-centre phase IIIb study will assess the effectiveness benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene gBRCA12 or sBRCA12 mutations
Detailed Description:
The study is a phase IIIb multicenter single-arm open-label study designed to evaluate the clinical effectiveness in a real-world setting of olaparib monotherapy in patients with confirmed germline or somatic breast cancer susceptibility gene gBRCA12 or sBRCA12 mutations This study will generate additional data to support other olaparib studies which may help inform and guide clinical practice Physician defined the progression-free survival PFS for gBRCAm patients is the primary outcome measure Based on the prevalence of gBRCA12 mutations it is estimated that up to 1400 patients may require screening in order to identify 250 gBRCA mutated patients and 20 sBRCA mutated patients Patients will be administered two olaparib 150mg tablets in morning and evening of every day after a light meal Dose reductions may be required for olaparib treatment related toxicities Patients should continue to receive study treatment until documented physician-defined disease progression as assessed by the investigator gBRCA mutated patients RECIST11 disease progression sBRCA mutated patients or unacceptable toxicity or for as long as they do not meet any other discontinuation criteria A positive benefitrisk profile is expected and no ethical issues are identified from exposing patients to olaparib within the planned clinical study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None