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NCT03344965 · ClinicalTrials.gov registry record · Phase 2
Olaparib In Metastatic Breast Cancer
A Phase 2 study of Metastatic Breast Cancer and Invasive Breast Cancer, sponsored by Beth Israel Deaconess Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 20
- Study locations
NCT03344965: Active Phase 2 study of Metastatic Breast Cancer and Invasive Breast Cancer, sponsored by Beth Israel Deaconess Medical Center.
NCT03344965 is a Phase 2 study of Metastatic Breast Cancer and Invasive Breast Cancer that is active but no longer recruiting, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 114 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03344965, a Phase 2 study of Metastatic Breast Cancer and Invasive Breast Cancer, is active but no longer recruiting, sponsored by Beth Israel Deaconess Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 20
- Study locations
Study Summary
This research study is for patients with metastatic breast cancer. * Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. * This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. * Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. * This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. * This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited.
Primary Outcome
RECIST 1.1 criteria will be reported with a two-sided 90% confidence interval using the method from Atkinson and Brown to account for the two-stage design
Conditions Studied
Interventions
- DRUG Olaparib
Study Locations (20)
New York
- Memorial Sloan Kettering Cancer Center Commack - Commack
- Memorial Sloan Kettering Cancer Center Westchester - East White Plains
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Cancer Center Nassau - Uniondale
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New Jersey
- Memorial Sloan Kettering Cancer Center Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Cancer Center Monmouth - Middletown
- Memorial Sloan Kettering Cancer Center Bergen - Montvale
Pennsylvania
- UPMC Hillman Cancer Center - Erie - Erie
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
Alabama
- University of Alabama at Birmingham - Birmingham
California
- University of California, San Francisco - San Francisco
Illinois
- University of Chicago - Chicago
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT03344965 still lists
NCT03344965 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (44% lower).
The record links to 10 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Olaparib is the first listed.
NCT03344965 names 20 study sites across 11 states, led by New York, Massachusetts, New Jersey.
Frequently Asked Questions
What is clinical trial NCT03344965 about?
NCT03344965 is a clinical study titled "Olaparib In Metastatic Breast Cancer". This research study is for patients with metastatic breast cancer. * Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA)...
What is the current status of trial NCT03344965?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2018-04-01. Estimated completion is 2026-06-30.
What conditions does trial NCT03344965 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Invasive Breast Cancer, ATM Gene Mutation, PALB2 Gene Mutation, BRIP1 Gene Mutation.
What interventions are being tested in trial NCT03344965?
The interventions under investigation include: Olaparib (DRUG).
Who is sponsoring clinical trial NCT03344965?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03344965 being conducted?
This trial has 20 study locations across Alabama, California, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03344965's enrollment target sits among peer trials
114 57th of 139 higher than 83 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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