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

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

May 31, 2014

Study Completion Date

August 31, 2017

Conditions
Breast Cancer
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."

Trial Locations (2)

66205

University of Kansas Medical Center Cancer Center, Kansas City

67601

Hays Medical Center, Hays

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

University of Kansas Medical Center

OTHER