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NCT01008150 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT01008150: Completed Phase 2 study of Breast Cancer, sponsored by NSABP Foundation.
NCT01008150 is a Phase 2 study of Breast Cancer that has completed, run by NSABP Foundation. The registered enrollment target is 141 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01008150, a Phase 2 study of Breast Cancer, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study Summary
FB-7 is a Phase II, multi-center randomized study of neratinib in combination with weekly paclitaxel with or without trastuzumab followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-positive locally advanced breast cancer. Patients in the control arm will receive neoadjuvant trastuzumab in combination with weekly paclitaxel followed by AC. The primary aim of the study is to determine the pathologic complete response (pCR) rate in breast and axillary nodes following the neoadjuvant therapy regimens. The secondary aims include determination of the pCR rate in breast only, clinical complete response (cCR) rate, two-year recurrence-free interval, two-year overall survival, toxicity of the neoadjuvant regimens, and exploration of molecular and genetic correlates of response.
Primary Outcome
Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Neratinib
- DRUG Paclitaxel
Study Locations (20)
Illinois
- Edward Cancer Center - Naperville
- Edward Cancer Center Plainfield - Plainfield
- Yorkville Family Practice - Yorkville
California
- Loma Linda University Medical Center - Loma Linda
- Kaiser Permanente-San Diego - San Diego
Idaho
- St. Luke's Mountain States Tumor Institute - Boise - Boise
- Kootenai Cancer Center - Post Falls
North Carolina
- CCOP Carolinas HealthCare System - Charlotte
- Wake Forest University School of Medicine - Winston-Salem
Ohio
- Case Western Reserve University/University Hospitals of Cleveland - Cleveland
- CCOP - Dayton - Dayton
Colorado
- CCOP - Colorado Cancer Research Program, Inc. - Denver
Connecticut
- Hartford Hospital - Hartford
Florida
- Baptist Cancer Institute - Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2010-10 |
| Est. Completion | 2016-11-25 |
| Phase | Phase 2 |
What the finished NCT01008150 record still lists
NCT01008150 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (95% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01008150 names 20 study sites across 14 states, led by Illinois, California, Idaho.
Frequently Asked Questions
What is clinical trial NCT01008150 about?
NCT01008150 is a clinical study titled "Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer". FB-7 is a Phase II, multi-center randomized study of neratinib in combination with weekly paclitaxel with or without trastuzumab followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-positive locally advanced breast cancer. Patients in the control arm will rece...
What is the current status of trial NCT01008150?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2010-10. Estimated completion is 2016-11-25.
What conditions does trial NCT01008150 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01008150?
The interventions under investigation include: Trastuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Neratinib (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01008150?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01008150 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Idaho. 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 NCT01008150's enrollment target sits among peer trials
141 462nd of 1224 higher than 762 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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