Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Bhuvaneswari Ramaswamy
Study ID
NCT00428922
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab — DRUG
    administered every three weeks on day 1, every 21 days. The dose given will be 6 mg/kg. The initial loading dose is 8mg/kg and is administered as a 90-minute infusion. Thereafter, the maintenance dose is 6mg/kg every three weeks administered as a 30 minute infusion (unless the treating physician indicates a longer infusion duration is warranted). Trastuzumab is given prior to bevacizumab. Trastuzumab is to be continued until disease progression or unacceptable toxicity.
  • Bevacizumab — DRUG
    administered every three weeks on day 1, every 21 days. The dose given will be 15 mg/kg. The initial dose is administered over 90 minutes. If the first infusion is well tolerated, the second dose is given over 60 minutes, and if that is well tolerated, then subsequent doses may be given over 30 minutes. Avastin is given after trastuzumab and prior to docetaxel.
  • Docetaxel — DRUG
    administered every three weeks on day 1, every 21 days. The dose given will be 75 mg/M². All doses of docetaxel are administered over 60 minutes. Docetaxel is given after trastuzumab and bevacizumab.

Study Details

The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.

Key Dates

First listed
Jan 30, 2007
Start date
Jun 14, 2007
Status verified
Jul 2018
Primary completion
Nov 1, 2012
Completion
Feb 7, 2017

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab, Bevacizumab, and Docetaxel
    Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]

Primary Outcome Measure

Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen. [ Time Frame: up to 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State UniversityColumbusOhio43210-
University of PittsburghPittsburghPennsylvania15213-

Find similar trials in Cleveland, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cleveland Clinic Foundation· Cleveland, OHOhio State University· Columbus, OHUniversity of Pittsburgh· Pittsburgh, PA

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