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NCT00915018 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 479
- Enrollment target
- 20
- Study locations
NCT00915018: Completed Phase 2 study of Breast Cancer, sponsored by Puma Biotechnology.
NCT00915018 is a Phase 2 study of Breast Cancer that has completed, run by Puma Biotechnology. The registered enrollment target is 479 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00915018, a Phase 2 study of Breast Cancer, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 479 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
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
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2009-08-21 |
| Est. Completion | 2018-06-28 |
| Phase | Phase 2 |
What the finished NCT00915018 record still lists
NCT00915018 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower).
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.
NCT00915018 names 20 study sites across 8 states, led by Florida, Illinois, Missouri.
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.
What interventions are being tested in trial NCT00915018?
The interventions under investigation include: Trastuzumab (DRUG), Neratinib (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00915018?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for 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 NCT00915018's enrollment target sits among peer trials
479 207th of 1224 higher than 1,018 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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