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COMPLETED Phase 2

Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

NCT00930930 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving chemotherapy together with everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether cisplatin and paclitaxel are more effective when given together with or without everolimus in treating patients with breast cancer. PURPOSE: This randomized phase II trial is studying how well cisplatin and paclitaxel work when given together with or without everolimus in treating patients with stage II or stage III breast cancer.

Conditions Studied

Interventions

  • OTHER placebo
  • DRUG cisplatin
  • DRUG paclitaxel
  • DRUG everolimus
  • PROCEDURE Venous blood draw

Study Locations (8)

Tennessee

  • Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville
  • MBCCOP - Meharry Medical College - Nashville — Nashville
  • Vanderbilt-Ingram Cancer Center — Nashville

Alabama

  • University of Alabama — Birmingham

Mississippi

  • University of Mississippi Medical Center Research Institute — Jackson

Pennsylvania

  • Hershey Medical Center — Hershey

Texas

  • The Methodist Hospital Research Institute — Houston

Virginia

  • University of Virginia Health Sciences Center — Charlottesville

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2009-06
Est. Completion 2014-10
Phase Phase 2

Sponsor

Vanderbilt-Ingram Cancer Center

143 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00930930

The ClinicalTrials.gov registry entry for NCT00930930 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00930930 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Tennessee, Alabama, Mississippi. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00930930 about?

NCT00930930 is a clinical study titled "Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and b...

What is the current status of trial NCT00930930?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2009-06. Estimated completion is 2014-10.

What conditions does trial NCT00930930 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00930930?

The interventions under investigation include: placebo (OTHER), cisplatin (DRUG), paclitaxel (DRUG), everolimus (DRUG), Venous blood draw (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00930930?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00930930 being conducted?

This trial has 8 study locations across Alabama, Mississippi, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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