Status:
COMPLETED
Fulvestrant and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, su...
Detailed Description
OBJECTIVES: Primary * Assess the efficacy of fulvestrant and bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with metastatic breast cancer previously treated with an ar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00423917
Start Date
August 1 2007
End Date
January 15 2017
Last Update
May 8 2018
Active Locations (205)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
3
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
4
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504