Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02227082
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2014-08-26
Brief Title:
Olaparib and Radiotherapy in Inoperable Breast Cancer
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Olaparib Dose Escalation in Combination With High Dose Radiotherapy to the Breast Andregional Lymph Nodes in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-08
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:
The majority of breast cancer patients receive radiotherapy as part of their treatment Radiotherapy improves both locoregional control and overall survival In most patients with breast cancer the locoregional recurrence rate LRR is low however still high LRRs are found in certain patient groups especially in locally advanced inflammatory and triple negative breast cancer Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for homologous recombination HR defected tumors and as a dose intensifier for chemo- and radiotherapy The combination of olaparib and radiotherapy is expected to improve locoregional control and thereby overall survival in both breast cancer patients with a high probability of locoregional recurrence and patients with HR deficient tumors However this combination treatment has never been tested in humans before The purpose of this study is to determine the safety and tolerability of radiotherapy to the breast and regional lymph nodes with concurrent olaparib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-001586-40 | EUDRACT_NUMBER | None | None |