Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women

Sponsor
Spanish Breast Cancer Research Group
Study ID
NCT00545077
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Letrozole — DRUG
  • Bevacizumab — DRUG
  • Fulvestrant — DRUG

Study Details

Locally advanced or metastatic breast cancer in postmenopausal women with negative Human Epidermal Growth Factor Receptor 2 (HER2), who are candidates for hormone treatment and who have not received previous chemotherapy or hormonotherapy for the metastatic disease.

Key Dates

First listed
Oct 17, 2007
Start date
Nov 6, 2007
Status verified
Mar 2023
Primary completion
Dec 31, 2013
Completion
Jul 24, 2014

Study Design

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

Arms

  • Active Comparator: Arm A: Endocrine Therapy (ET)
    Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.
  • Experimental: Arm B: ET with Bevacizumab (ET-B)
    Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]

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