Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00365365
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Doxorubicin and cyclophosphamide (AC) + bevacizumab — DRUG
    For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 60 mg/m\^2 IV push or infusion followed by cyclophosphamide 600 mg/m\^2 IV push or infusion * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
  • Docetaxel (T) + bevacizumab — DRUG
    For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * docetaxel 100 mg/m\^2 IV * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy Note: The starting dose of docetaxel was reduced to 75 mg/m\^2 if toxicity occurred that met the criteria for doxorubicin dose reduction
  • Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab — DRUG
    For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 50 mg/m\^2 IV push or infusion followed by cyclophosphamide 500 mg/m\^2 IV push or infusion followed by docetaxel 75 mg/m\^2 * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
  • Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab — DRUG
    For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * docetaxel in 75 mg/m\^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by * trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2) * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
  • Bevacizumab and trastuzumab maintenance therapy — DRUG
    * bevacizumab 15 mg/kg was infused IV followed by * trastuzumab 6 mg/kg IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.
  • Bevacizumab maintenance therapy — DRUG
    \- bevacizumab 15 mg/kg was infused IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.

Study Details

This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.

Key Dates

First listed
Aug 17, 2006
Start date
Aug 31, 2006
Status verified
Jan 2012
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

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

Arms

  • Experimental: Stratum 1 (AC->T + bevacizumab)
    HER2-negative participants administered * doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by * docetaxel (T) + bevacizumab for 4 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed
  • Experimental: Stratum 2 (TAC + bevacizumab)
    HER2-negative participants administered * docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed
  • Experimental: Stratum 3 (TCH + bevacizumab)
    All HER2-positive participants administered * docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by * bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed

Primary Outcome Measure

Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF) [ Time Frame: from the first dose of study medication up to the end of follow-up (up to 3 yrs) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

Find similar trials in Bridgewater, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sanofi-Aventis Administrative Office· Bridgewater, NJ

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