Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
Public ClinicalTrials.gov record NCT01705691. 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 Chemotherapy Regimens With Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women With Locally Advanced HER2-Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.
Study identification
- NCT ID
- NCT01705691
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
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
- Aug 31, 2012
- Primary completion
- Feb 28, 2014
- Completion
- Sep 30, 2015
- Last update posted
- Oct 5, 2021
2012 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CCOP, Colorado Cancer Research Program, Inc. | Denver | Colorado | 80222 | — |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31703 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Carolinas Medical Center/Levine Cancer Center | Charlotte | North Carolina | 28203 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Allegheny General Hospital/Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | — |
| NSABP Foundation, Inc. | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232-1305 | — |
| Roper Hospital | Charleston | South Carolina | 29401 | — |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29615 | — |
| Joe Arrington Cancer Research & Treatment Center | Lubbock | Texas | 79410 | — |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | 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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01705691, 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 5, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01705691 live on ClinicalTrials.gov.