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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 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.

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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.

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

FieldValue
Enrollment Target 31 participants
Start Date 2013-11
Est. Completion 2018-05
Phase Phase 1

Sponsor

University of Chicago

796 total trials

What the Registry Record Tells You About NCT02046421

The ClinicalTrials.gov registry entry for NCT02046421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (53% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.