Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03598257 |
Recruitment Status :
Recruiting
First Posted : July 26, 2018
Last Update Posted : January 27, 2023
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | July 24, 2018 | ||||
First Posted Date ICMJE | July 26, 2018 | ||||
Last Update Posted Date | January 27, 2023 | ||||
Actual Study Start Date ICMJE | September 12, 2018 | ||||
Estimated Primary Completion Date | June 1, 2027 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Invasive Disease-Free Survival (IDFS) [ Time Frame: Up to 8 years ] 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 and Meier and will compare the time-to-event distributions using log-rank test statistics. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups.
|
||||
Original Primary Outcome Measures ICMJE |
Invasive disease-free survival (IDFS) [ Time Frame: Up to 8 years ] Analysis will be on an intent-to-treat basis and will estimate the survival endpoints using the product-limit method of Kaplan and Meier and will compare the time-to-event distributions using log-rank test statistics. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups.
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
Locoregional recurrence-free interval [ Time Frame: Up to 8 years ] A competing risk framework will be conducted separating out the event types of locoregional recurrence from distant recurrence and death. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups.
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer | ||||
Official Title ICMJE | A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer | ||||
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. 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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Breast Inflammatory Carcinoma | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Michmerhuizen AR, Pesch AM, Moubadder L, Chandler BC, Wilder-Romans K, Cameron M, Olsen E, Thomas DG, Zhang A, Hirsh N, Ritter CL, Liu M, Nyati S, Pierce LJ, Jagsi R, Speers C. PARP1 Inhibition Radiosensitizes Models of Inflammatory Breast Cancer to Ionizing Radiation. Mol Cancer Ther. 2019 Nov;18(11):2063-2073. doi: 10.1158/1535-7163.MCT-19-0520. Epub 2019 Aug 14. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
300 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2027 | ||||
Estimated Primary Completion Date | June 1, 2027 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Canada, Puerto Rico, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03598257 | ||||
Other Study ID Numbers ICMJE | NCI-2018-01519 NCI-2018-01519 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S1706 ( Other Identifier: SWOG ) S1706 ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | National Cancer Institute (NCI) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | National Cancer Institute (NCI) | ||||
Verification Date | November 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |