Clinical trial NCT00423917 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: fulvestrant
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed breast cancer

               -  Metastatic disease

          -  Must have received an aromatase inhibitor (e.g., letrozole, anastrozole, or
             exemestane) in an adjuvant or metastatic setting

          -  If tumor is HER2 positive (3+ by immunohistochemistry or amplified by fluorescent in
             situ hybridization) the patient must have received ≥ 1 prior trastuzumab
             (Herceptin®)-containing regimen unless there is a contraindication to trastuzumab

          -  Measurable or nonmeasurable disease, including any of the following :

               -  Bone metastasis

               -  Pleural/pericardial effusion

               -  Ascites

               -  Inflammatory skin changes

          -  No microscopic residual disease only

          -  Enrolled on or refused enrollment on clinical trial NCCTG-N0392

          -  No evidence of active brain metastasis including leptomeningeal involvement

               -  CNS metastasis controlled (i.e., at least 2 months of no symptoms or evidence of
                  progression) by prior surgery and/or raditherapy are allowed

          -  Hormone receptor status:

               -  Estrogen and/or progesterone receptor-positive tumor

        PATIENT CHARACTERISTICS:

          -  Male or female

          -  Female patients must be post-menopausal based on any 1 of the following criteria:

               -  Age ≥ 60 years

               -  Age ≥ 45 years with last menstrual period ≥ 12 months prior to study entry

               -  Estradiol and follicle-stimulating hormone levels in postmenopausal range

               -  History of bilateral oophorectomy

          -  ECOG performance status 0-2

          -  Life expectancy > 3 months

          -  Fertile patients must use effective contraception during and for 30 days after
             completion of study treatment

          -  WBC ≥ 3,000 mg/dL

          -  Hemoglobin > 8 g/dL

          -  Absolute neutrophil count > 1,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  AST and ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Urine protein < 1+ OR < 1 g of protein by 24-hour urine collection

               -  No nephrotic syndrome

          -  No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2
             occasions at least 5 minutes apart)

               -  Patients who have recently started or adjusted antihypertensive medications are
                  eligible provided BP is < 140/90 mm Hg on any new regimen for ≥ 3 different
                  observations in ≥ 14 days

          -  No clinically significant cardiac disease, including any of the following:

               -  Congestive heart failure

               -  Symptomatic coronary artery disease

               -  Unstable angina

               -  Cardiac arrhythmias not well controlled with medication

               -  Myocardial infarction within the past 12 months

          -  No arterial or venous thrombosis within the past 12 months

          -  No hemoptysis or gastrointestinal hemorrhage within the past 6 months

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 4 weeks

          -  No significant traumatic injury within the past 4 weeks

          -  No active, unresolved infection

          -  No history of hypertensive crisis or hypertensive encephalopathy

          -  No history of bleeding diathesis or uncontrolled coagulopathy

          -  No history of cerebrovascular accident, hemorrhage, or stroke

          -  No allergy or hypersensitivity to drug product excipients, murine antibodies, or
             agents chemically similar to study drugs

          -  No other malignancy within the past 3 years except for basal cell or squamous cell
             skin cancer or carcinoma in situ of the cervix

          -  No other serious medical condition that would preclude study therapy or compliance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Prior radiotherapy to a target lesion allowed provided there has been clear
             progression since radiotherapy was completed

          -  At least 4 weeks since prior radiotherapy

               -  Single-dose radiation for palliation or to a nontarget lesion only allowed within
                  the past 4 weeks

          -  No more than 1 prior chemotherapy regimen for metastatic disease

          -  No more than 2 prior endocrine (hormonal) therapy regimens in the neoadjuvant,
             adjuvant, or metastatic setting

          -  At least 4 weeks since prior major surgery or open biopsy

          -  At least 4 weeks since prior chemotherapy or immunologic therapy

          -  At least 2 weeks since prior and no concurrent use of any of the following agents:

               -  Aspirin (daily low-dose [81 mg] aspirin allowed])

               -  Thrombolytic agents

               -  Anticoagulants (low-dose anticoagulation therapy to maintain patency of a
                  vascular access device is allowed)

          -  No concurrent treatment in another clinical study with investigational procedures or
             investigational therapies

          -  No other concurrent anticancer therapy, including chemotherapy, biologic agents, or
             radiotherapy

          -  No routine use of granulocyte colony-stimulating factors during course 1

          -  No concurrent oprelvekin