A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

Part of paid clinical trials in Fullerton, California.

Sponsor
Genentech, Inc.
Study ID
NCT00262067
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Patients received bevacizumab until disease progression, treatment limiting toxicity, or death due to any cause up to a maximum treatment duration of 48 months. The dose of bevacizumab was based on the patient's weight at either screening or baseline and remained the same throughout the blinded treatment phase of the study. The initial dose was delivered over 90±10 minutes. If there were no infusion related adverse events (fever and/or chills), the second infusion was delivered over 60±10 minutes. If the 60 minute infusion was well tolerated, all subsequent infusions were delivered over 30±10 minutes.
  • Placebo — DRUG
    Placebo consisted of the vehicle for bevacizumab without the antibody.
  • Chemotherapy — DRUG
    The chemotherapy was selected by the investigator prior to randomization. Chemotherapy treatment continued until disease progression, unacceptable toxicity, investigator/patient decision, or death, whichever occurred first, except for the anthracycline-based regimens, which had a maximum treatment duration of 8 cycles. Taxanes - 1 of the following 2 taxanes on Day 1 of every 21-day cycle 1. Docetaxel 75-100 mg/m\^2 IV 2. Paclitaxel protein-bound particles (Abraxane®) 260 mg/m\^2 IV Anthracyclines - 1 of the following 4 anthracycline-based regimens on Day 1 of every 21-day cycle 1. 5-fluorouracil 500 mg/m\^2 IV + epirubicin 90-100 mg/m\^2 IV + cyclophosphamide 500 mg/m\^2 IV 2. 5-fluorouracil 500 mg/m\^2 IV + doxorubicin 50 mg/m\^2 IV + cyclophosphamide 500 mg/m\^2 IV 3. Doxorubicin 50-60 mg/m\^2 IV + cyclophosphamide 500-600 mg/m\^2 IV 4. Epirubicin 90-100 mg/m\^2 IV + cyclophosphamide 500-600 mg/m\^2 IV Capecitabine: 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day cycle

Study Details

This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.

Key Dates

First listed
Dec 6, 2005
Start date
Dec 31, 2005
Status verified
Nov 2013
Primary completion
Jul 31, 2008
Completion
Dec 31, 2013

Study Design

Enrollment
1,237 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + chemotherapy
    Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle plus one of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer.
  • Placebo Comparator: Placebo + chemotherapy
    Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + 1 of several standard chemotherapies (taxanes, anthracycline-based regimens, or capecitabine) for metastatic breast cancer.

Primary Outcome Measure

Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
-FullertonCalifornia92835-
-Santa BarbaraCalifornia93105-
-Iowa CityIowa52242-
-Sioux CityIowa51101-
-WichitaKansas67214-3728-

Find similar trials in Fullerton, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health

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