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Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

NCT01498588 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-10-03

Study results available
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Summary

Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow the patient to have less extensive surgery. The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.

Conditions

  • Breast Neoplasms
  • Breast Cancer
  • Breast Tumors
  • Cancer of the Breast
  • Neoplasms, Breast
  • Tumors, Breast

Interventions

DRUG

Eribulin

Patients will receive 4 cycles of neoadjuvant eribulin followed by 4 cycles of dose-dense doxorubicin and cyclophosphamide (AC).

DRUG

Doxorubicin

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

DRUG

Cyclophosphamide

Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

DRUG

Pegfilgrastim

Growth factor support (pegfilgrastim) can be given at the discretion of the investigator. Administration of pegfilgrastim is required 24 to 48 hours following administration of dose-dense doxorubicin and cyclophosphamide.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Keerthi Gogineni, MD, MSHP · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01498588 on ClinicalTrials.gov