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COMPLETED 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

NCT01008150 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 141 participants
Start Date 2010-10
Est. Completion 2016-11-25
Phase Phase 2

Sponsor

NSABP Foundation

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01008150

The ClinicalTrials.gov registry entry for NCT01008150 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01008150 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Illinois, California, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01008150?

The interventions under investigation include: Trastuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Neratinib (DRUG), Paclitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01008150?

This trial is sponsored by NSABP Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial