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Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression

NCT00944047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-04-23

Study results available
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Summary

The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.

Conditions

Interventions

DRUG

nab-paclitaxel

100 MG/M2 IV over 30 minutes once a week for 12 weeks

DRUG

trastuzumab

4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks

DRUG

Doxorubicin

60 MG/M2 every two weeks for a total of 4 cycles

DRUG

cyclophosphamide

600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)

BIOLOGICAL

Growth Factor Support

* All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle. * Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.

PROCEDURE

Surgery

* After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy. * All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Qamar Khan, MD · University of Kansas Medical Center Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-05-31
Completion
2017-08-31

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 NCT00944047 on ClinicalTrials.gov