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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT00394251
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adriamycin and Cytoxan (AC) — DRUG
    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).
  • ABI-007 — DRUG
    260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
  • Taxol — DRUG
    175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16)
  • Bevacizumab — DRUG
    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).
  • pegfilgrastim — DRUG
    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.

Study Details

The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.

Key Dates

First listed
Oct 31, 2006
Start date
Aug 1, 2006
Status verified
Nov 2019
Primary completion
Mar 1, 2007
Completion
Feb 1, 2008

Study Design

Enrollment
197 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AC --> ABI-007
    Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m\^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
  • Experimental: AC --> Taxol
    Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m\^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).

Primary Outcome Measure

Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy [ Time Frame: Month 7 ]

Locations (27)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35205-
-SedonaArizona86336-
-DenverColorado80220-
-TorringtonConnecticut06790-
-IndianapolisIndiana46227-
-MinneapolisMinnesota55404-
-ColumbiaMissouri65201-
-St LouisMissouri63136-
-HendersonNevada89052-
-RaleighNorth Carolina27607-
-EugeneOregon97401-
-GreenvilleSouth Carolina29615-
-AustinTexas78731-
-BedfordTexas76022-
-DallasTexas75231-
-DallasTexas75246-
-El PasoTexas79915-
-Fort WorthTexas76104-
-FredericksburgTexas78624-
-HoustonTexas77024-
-LongviewTexas75601-
-McAllenTexas78503-
-TylerTexas75702-
-WacoTexas76712-
-FairfaxVirginia22031-
-NorfolkVirginia23502-
-VancouverWashington98684-

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By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health

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