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
Public ClinicalTrials.gov record NCT01008150. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens With Weekly Paclitaxel Plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide With Postoperative Trastuzumab in Women With Locally Advanced HER2-Positive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01008150
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 141 participants
Conditions and interventions
Conditions
Interventions
- Paclitaxel Drug
- Trastuzumab Drug
- Neratinib Drug
- Doxorubicin Drug
- Cyclophosphamide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Aug 31, 2015
- Completion
- Nov 24, 2016
- Last update posted
- Oct 24, 2021
2010 – 2016
United States locations
- U.S. sites
- 30
- U.S. states
- 19
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Kaiser Permanente-San Diego | San Diego | California | 92120 | — |
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80224 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | — |
| St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | 83712 | — |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | — |
| Edward Cancer Center | Naperville | Illinois | 60540 | — |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | — |
| Yorkville Family Practice | Yorkville | Illinois | 60560 | — |
| St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | 46260 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| University of Missouri-Ellis Fischel | Columbia | Missouri | 65203 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| University Hospital and Medical Center - SUNY Stony Brook | Stony Brook | New York | 11794 | — |
| CCOP Carolinas HealthCare System | Charlotte | North Carolina | 28232-2861 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Case Western Reserve University/University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| CCOP - Dayton | Dayton | Ohio | 45409 | — |
| CCOP - Dayton | Kettering | Ohio | 45429 | — |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| NSABP Foundation, Inc. | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232-1305 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Roper Hosp & Med Asso (Care Alliance Health) | Charleston | South Carolina | 29401 | — |
| Spartanburg Regional Healthcare System | Spartanburg | South Carolina | 29303 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298 | — |
| West Virginia University Hospitals Inc. | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01008150, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 24, 2021 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01008150 live on ClinicalTrials.gov.