Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

Key facts

Study ID

NCT00217399

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2005-06-01

Expected to finish

2013-01-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed breast cancer
• Metastatic disease
• Measurable disease, defined as >=1 unidimensionally measurable lesion, including >= 1 of the following:
• Lesion >= 10 mm on CT scan (5 mm sections)
• Lesion >= 20 mm on CT scan or MRI (10 mm sections)
• Bone disease that is >= 10 mm on MRI
• Lytic bone lesions that are >= 10 mm on CT scan (with 5 mm sections) OR >= 20 mm on plain film or CT scan (with 10 mm sections)
• Lesion >= 10 mm on physical exam
• Patients must have received >= 1 prior aromatase inhibitor in either the adjuvant or metastatic setting and must have had either disease recurrence or disease progression on a prior aromatase inhibitor therapy
• No brain metastases diagnosed within the past 6 months OR previously untreated brain metastases
• Estrogen receptor-positive and/or progesterone receptor-positive, defined as > 1% staining by immunohistochemistry or > 10 fmol/mg of protein by radio-ligand dextran-coated steroid binding assay
• Postmenopausal, as defined by 1 of the following:
• Prior bilateral oophorectomy
• No menses for >= 12 months in patients with an intact uterus
• Follicle-stimulating hormone (FSH) in postmenopausal range in patients < 60 years of age who have had a prior hysterectomy or have been amenorrheic for >= 3 months
• Age >= 60 years
• Pre- or perimenopausal patients receiving monthly injections of goserelin at a dose of 3.6 mg are eligible
• ECOG 0-2
• More than 3 months
• Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis
• Bilirubin =< 1.5 times upper limit of normal (ULN AST and ALT =< 2.5 times ULN
• Systolic blood pressure (BP) < 150 mm Hg and diastolic BP < 100 mm Hg on at least one reading prior to study entry No uncontrolled hypertension
• None of the following within the past 6 months:
• Symptomatic congestive heart failure
• Unstable angina pectoris

You may not qualify if…

• estrogen receptor status unknown
• history of myocardial infarction within 6 months
• performance status 3
• performance status 4
• premenopausal
• progesterone receptor status unknown
• HIV positive

Where it is running

• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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