drugset / Trial / NCT00138125

Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT00138125 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, 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. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.

Timeline

Start
2005-04
Primary completion
2009-09
Completion
2009-12

Outcome

Outcome not reported

Stopped (Enrollment): “Due to low accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications