Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Eastern Cooperative Oncology Group
Study ID
NCT00028990
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle
  • Paclitaxel — DRUG
    90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest

Study Details

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer. PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.

Key Dates

First listed
Jan 27, 2003
Start date
Jan 29, 2002
Status verified
Jun 2023
Primary completion
Nov 30, 2006
Completion
May 31, 2009

Study Design

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

Arms

  • Active Comparator: Paclitaxel + Bevacizumab
  • Active Comparator: Paclitaxel

Primary Outcome Measure

Progression-Free Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]

Locations (28)

FacilityCityStateZIPSite coordinators
MBCCOP - Gulf CoastMobileAlabama36607-
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdaleArizona85259-5404-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
CCOP - Atlanta RegionalAtlantaGeorgia30342-1701-
CCOP - Illinois Oncology Research AssociationPeoriaIllinois61602-
CCOP - Carle Cancer CenterUrbanaIllinois61801-
CCOP - Cedar Rapids Oncology ProjectCedar RapidsIowa52403-1206-
CCOP - Iowa Oncology Research AssociationDes MoinesIowa50309-1016-
Siouxland Hematology-OncologySioux CityIowa51101-1733-
CCOP - OchsnerNew OrleansLouisiana70121-
CCOP - Michigan Cancer Research ConsortiumAnn ArborMichigan48106-
CCOP - DuluthDuluthMinnesota55805-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CentraCare Health PlazaSaint CloudMinnesota56303-
CCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106-
Medcenter One Health SystemBismarckNorth Dakota58501-5505-
CCOP - Merit Care HospitalFargoNorth Dakota58122-
Altru Cancer CenterGrand ForksNorth Dakota58201-
CCOP - DaytonDaytonOhio45429-
CCOP - Toledo Community HospitalToledoOhio43623-3456-
CCOP - OklahomaTulsaOklahoma74136-
CCOP - Geisinger Clinic and Medical CenterDanvillePennsylvania17822-2001-
Allegheny General HospitalPittsburghPennsylvania15212-4772-
CCOP - Upstate CarolinaSpartanburgSouth Carolina29303-
Rapid City Regional HospitalRapid CitySouth Dakota57709-
CCOP - Sioux Community Cancer ConsortiumSioux FallsSouth Dakota57104-
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen BayWisconsin54301-

Find similar trials in Mobile, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MBCCOP - Gulf Coast· Mobile, ALCCOP - Mayo Clinic Scottsdale Oncology Program· Scottsdale, AZMayo Clinic - Jacksonville· Jacksonville, FLCCOP - Atlanta Regional· Atlanta, GACCOP - Illinois Oncology Research Association· Peoria, ILCCOP - Carle Cancer Center· Urbana, IL

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