Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00083031
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
  • cyclophosphamide — DRUG
  • methotrexate — DRUG

Study Details

This randomized phase II trial is studying metronomic low-dose cyclophosphamide and methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide, methotrexate, and bevacizumab in treating women with metastatic breast cancer.

Key Dates

First listed
May 17, 2004
Start date
Jul 31, 2003
Status verified
May 2019
Primary completion
Aug 31, 2006
Completion
Aug 31, 2009

Study Design

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

Arms

  • Experimental: Arm A-Bevacizumab
    * Methotrexate- twice daily on predetermined days per each week per cycle * Cyclophosphamide- oral, daily, predetermined dose * Bevacizumab- Via IV on predetermined days per cycle
  • Experimental: Arm B- Without Bevacizumab
    * Methotrexate- twice daily on predetermined days per each week per cycle * Cyclophosphamide- oral, daily, predetermined dose

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Disease evaluations occurred every 8 weeks for the first 6 cycles and every 12 weeks thereafter until progression, death or lost-to-follow-up. Patients were followed for ORR up to approximately 1 year. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HosptialBostonMassachusetts02114-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hosptial· Boston, MASarah Cannon Research Institute· Nashville, TN

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