Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-05 @ 12:25 PM
Study NCT ID:
NCT03598257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2018-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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 phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes.
SECONDARY OBJECTIVE:
I. To compare the effect of concurrent administration of olaparib with radiotherapy versus radiotherapy alone on improvement in locoregional control (measured by locoregional recurrence-free interval), distant relapse-free survival, and overall survival in inflammatory breast cancer patients.
ADDITIONAL OBJECTIVE:
I. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive olaparib orally (PO) twice daily (BID) the day before standard radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of RT administration. Olaparib is also continued on weekends (routine days without RT) throughout the RT course. Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 5 weeks, then every 3 months until 3 years after registration, and then every 6 months for up to 8 years after registration.
I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes.
SECONDARY OBJECTIVE:
I. To compare the effect of concurrent administration of olaparib with radiotherapy versus radiotherapy alone on improvement in locoregional control (measured by locoregional recurrence-free interval), distant relapse-free survival, and overall survival in inflammatory breast cancer patients.
ADDITIONAL OBJECTIVE:
I. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive olaparib orally (PO) twice daily (BID) the day before standard radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of RT administration. Olaparib is also continued on weekends (routine days without RT) throughout the RT course. Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 5 weeks, then every 3 months until 3 years after registration, and then every 6 months for up to 8 years after registration.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01519 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| S1706 | OTHER | SWOG | View | |
| S1706 | OTHER | CTEP | View | |
| U10CA180888 | NIH | None | https://reporter.nih.gov/quic… | View |