Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer
Condition: Breast Cancer; Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Bevacizumab; Anastrozole; Fulvestrant
Intervention description: Bevacizumab 10mg/kg IV every 2 weeks; anastrozole (1 mg orally daily); fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg IM of fulvestrant).
Intervention MeSH terms: Bevacizumab; Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Metastatic breast cancer; Bevacizumab; Anastrozole; Fulvestrant

Summary:

      This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with
      trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped
      that these combinations will keep the cancer from growing and spreading further.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR)
             receptor positive that is locally advanced or locally recurrent and not able to be
             surgically removed OR with measurable and/or disease that is able to be assessed
             including isolated bone metastasis

          -  Female patients 18 years or older

          -  Documentation of ER+ and/or PR+

          -  No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable
             breast cancer that is locally recurrent or locally advanced

          -  Measurable or evaluable disease

          -  Radiation therapy to painful bone lesions or impending fractures is allowed as long as
             there is measurable or evaluable disease outside the radiated area.

          -  Must have adequate bone marrow, renal and liver function

          -  Patients receiving prior treatment with an anthracycline based chemotherapy must have
             a normal left ventricle ejection fraction

        Exclusion Criteria:

          -  No metastatic disease to the Central Nervous System

          -  No history of myocardial infarction (MI), stroke or transient ischemic attacks in the
             last 6 months

          -  No symptoms of peripheral vascular disease

          -  No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess
             in the past 6 months

          -  No known hypersensitivity to phosphate, trehalose or polysorbate

          -  No serious non-healing wound, ulcer or bone fracture

          -  No uncontrolled high blood pressure or history of hypertensive crisis

          -  No New York Hear Association class II congestive heart failure

          -  No extensive cancer involvement of the liver or lungs

          -  No history of significant psychiatric disorders

          -  No significant vascular disease

        There are additional inclusion/exclusion criteria. The study center will determine if you
        meet all of the criteria. If you do not qualify for the trial, study personnel will explain
        the reasons. If you do qualify, study personnel will explain the trial in detail and answer
        any questions you may have. You can then decide if you wish to participate.