Fulvestrant and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
• fulvestrant — DRUG

Study Details

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with bevacizumab may be an effective treatment for metastatic breast cancer. PURPOSE: This phase II trial is studying how well giving fulvestrant together with bevacizumab works in treating patients with metastatic breast cancer.

Key Dates

First listed

Jan 18, 2007

Start date

Aug 31, 2007

Status verified

Apr 2018

Primary completion

Feb 28, 2009

Completion

Jan 15, 2017

Study Design

Enrollment

36 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: fulvestrant + bevacizumab
  Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to every other course, and at the completion of study treatment. After completion of study treatment, patients are followed every 3-6 months for 5 years.

Primary Outcome Measure

Six-month Progression-free Survival (PFS) Rate at 6 Months [ Time Frame: at 6 months ]

Locations (205)

Find similar trials in Scottsdale, AZ

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