Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

August 1, 2006

Primary Completion Date

March 1, 2007

Study Completion Date

February 1, 2008

Conditions
Breast Cancer
Interventions
DRUG

Adriamycin and Cytoxan (AC)

Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8).

DRUG

ABI-007

260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)

DRUG

Taxol

175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)

DRUG

Bevacizumab

10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46).

DRUG

pegfilgrastim

6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary.

Trial Locations (27)

22031

Fairfax

23502

Norfolk

27607

Raleigh

29615

Greenville

35205

Birmingham

46227

Indianapolis

55404

Minneapolis

63136

St Louis

65201

Columbia

75231

Dallas

75246

Dallas

75601

Longview

75702

Tyler

76022

Bedford

76104

Fort Worth

76712

Waco

77024

Houston

78503

McAllen

78624

Fredericksburg

78731

Austin

79915

El Paso

80220

Denver

86336

Sedona

89052

Henderson

97401

Eugene

98684

Vancouver

06790

Torrington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY