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Completed Phase 2 Interventional Results available

Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

ClinicalTrials.gov ID: NCT01705691

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.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 6:05 AM EDT

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
Lead sponsor
NSABP Foundation Inc
Network
Enrollment
50 participants

Conditions and interventions

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 2012 (Type not available)
Primary completion
Mar 2014 (Actual)
Completion
Oct 2015 (Actual)
Last update posted
Oct 6, 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 6, 2021 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01705691 live on ClinicalTrials.gov.

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