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COMPLETED Phase 2

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

NCT00915018 · View on ClinicalTrials.gov ↗

Study Summary

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

Conditions Studied

Interventions

  • DRUG Trastuzumab
  • DRUG Neratinib
  • DRUG Paclitaxel

Study Locations (20)

Florida

  • Palm Beach Institute of Hematology and Oncology — Boynton Beach
  • North Broward Medical Center Cancer Center — Deerfield Beach
  • Broward General Medical Center — Fort Lauderdale
  • Mid Florida Cancer Centers — Orange City
  • Florida Cancer Research Institute — Plantation
  • Hematology Oncology Associates of Treasure Coast — Port Saint Lucie

Illinois

  • Clintell — Skokie
  • Presence Hematology and Oncology — Skokie
  • Springfield Clinic — Springfield

Missouri

  • Missouri Cancer Associates — Columbia
  • St. John's Medical Research Institute — Springfield
  • Washington University School of Medicine Siteman Cancer Center — St Louis

California

  • Ventura County Hematology-Oncology Specialists — Oxnard
  • Redwood Regional Medical Group — Santa Rosa

Georgia

  • Phoebe Cancer Center — Albany
  • Dublin Hematology and Oncology Care — Dublin

Louisiana

  • CHRISTUS St. Frances Cabrini Hospital — Alexandria
  • Hematology Oncology Services — Metairie

Connecticut

  • Cancer Center of Central Connecticut — Plainville

Minnesota

  • Park Nicollet Institute — Saint Louis Park

Trial Details

FieldValue
Enrollment Target 479 participants
Start Date 2009-08-21
Est. Completion 2018-06-28
Phase Phase 2

Sponsor

Puma Biotechnology

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00915018

The ClinicalTrials.gov registry entry for NCT00915018 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 479 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 6 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 3 interventions — of which Trastuzumab 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: NCT00915018 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Illinois, Missouri. 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 NCT00915018 about?

NCT00915018 is a clinical study titled "Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer". This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The stud...

What is the current status of trial NCT00915018?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 479 participants. The study started on 2009-08-21. Estimated completion is 2018-06-28.

What conditions does trial NCT00915018 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 NCT00915018?

The interventions under investigation include: Trastuzumab (DRUG), Neratinib (DRUG), Paclitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00915018?

This trial is sponsored by Puma Biotechnology, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00915018 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. 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