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NCT03598257 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
A Phase 2 study of Breast Inflammatory Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT03598257: Active Phase 2 study of Breast Inflammatory Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03598257 is a Phase 2 study of Breast Inflammatory Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 300 participants, above the 189-participant average among 3 other Breast Inflammatory Carcinoma trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598257, a Phase 2 study of Breast Inflammatory Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. Analysis will be on an intent-to-treat basis and will estimate the survival endpoints using the product-limit method of Kaplan-Meier and will compare the time-to-event distributions using log-r
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Survey Administration
- DRUG Olaparib
- RADIATION Radiation Therapy
Study Locations (20)
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Epic Care Partners in Cancer Care - Emeryville
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Fremont - Rideout Cancer Center - Marysville
- Desert Regional Medical Center - Palm Springs
- Palo Alto Medical Foundation Health Care - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
- Gene Upshaw Memorial Tahoe Forest Cancer Center - Truckee
- Sutter Solano Medical Center/Cancer Center - Vallejo
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-01-18 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What the registry record for NCT03598257 still lists
NCT03598257 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 189-participant average among 3 other Breast Inflammatory Carcinoma trials with a reported enrollment target (59% higher).
The record links to 1 condition, with Breast Inflammatory Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT03598257 names 20 study sites across 4 states, led by California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT03598257 about?
NCT03598257 is a clinical study titled "Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer". 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 ...
What is the current status of trial NCT03598257?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2019-01-18. Estimated completion is 2027-06-01.
What conditions does trial NCT03598257 study?
This clinical trial studies the following conditions: Breast Inflammatory Carcinoma.
What interventions are being tested in trial NCT03598257?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Survey Administration (OTHER), Olaparib (DRUG), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03598257?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03598257 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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