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NCT02046421 · ClinicalTrials.gov registry record · Phase 1
Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study of Stage IV Breast Cancer and Stage IIIB Breast Cancer, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT02046421: Completed Phase 1 study of Stage IV Breast Cancer and Stage IIIB Breast Cancer, sponsored by University of Chicago.
NCT02046421 is a Phase 1 study of Stage IV Breast Cancer and Stage IIIB Breast Cancer that has completed, run by University of Chicago. The registered enrollment target is 31 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02046421, a Phase 1 study of Stage IV Breast Cancer and Stage IIIB Breast Cancer, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and mifepristone when given together with carboplatin in treating patients with breast cancer that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Steroid hormones can cause the growth of cancer cells. Hormone therapy using mifepristone may fight breast and ovarian cancer by lowering the amount of steroid hormone the body makes. Giving carboplatin and gemcitabine hydrochloride together with mifepristone may be an effective treatment for breast, ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Primary Outcome
Summarized by type and grade overall and for each dose level. Confidence intervals for the proportion of patients experiencing a DLT will be constructed.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG carboplatin
- OTHER pharmacological study
- DRUG gemcitabine hydrochloride
- DRUG mifepristone
Study Locations (2)
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-05 |
| Phase | Phase 1 |
What the finished NCT02046421 record still lists
NCT02046421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (53% lower).
The record links to 8 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT02046421 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02046421 about?
NCT02046421 is a clinical study titled "Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer". This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and mifepristone when given together with carboplatin in treating patients with breast cancer that is metastatic or cannot be removed by surgery or recurrent or persistent ovarian epithelial, fallopian tube, or pr...
What is the current status of trial NCT02046421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-11. Estimated completion is 2018-05.
What conditions does trial NCT02046421 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Recurrent Breast Cancer, Male Breast Cancer.
What interventions are being tested in trial NCT02046421?
The interventions under investigation include: laboratory biomarker analysis (OTHER), carboplatin (DRUG), pharmacological study (OTHER), gemcitabine hydrochloride (DRUG), mifepristone (DRUG).
Who is sponsoring clinical trial NCT02046421?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02046421 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV 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 NCT02046421's enrollment target sits among peer trials
31 13th of 30 higher than 16 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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