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Phase II Trial of Fulvestrant and Bevacizumab in Patients With Metastatic Breast Cancer Previously Treated With an Aromatase Inhibitor

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of Fulvestrant and Bevacizumab in Patients With Metastatic Breast Cancer Previously Treated With an Aromatase Inhibitor



- 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 aromatase inhibitor.


- Assess the quality of life of patients treated with this regimen.

- Determine the adverse-event profile in these patients.

- Determine the PFS and overall survival of these patients.

- Determine the confirmed response rate, duration of response, time to treatment failure,
and time to first cytotoxic agent in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes
on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed at baseline, prior to every other course, and at the completion
of study treatment.

After completion of study treatment, patients are followed every 3-6 months for 5 years.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

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

- No concurrent oprelvekin

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-month progression-free survival (PFS) rate

Safety Issue:


Principal Investigator

Winston Tan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
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CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
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Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
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Avera Cancer Institute Sioux Falls, South Dakota  57105
Methodist Medical Center of Illinois Peoria, Illinois  61636
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Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
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Hinsdale, Illinois  60521
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Toledo Hospital Toledo, Ohio  43606
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Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
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Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
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Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
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Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
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John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
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Community Cancer Center of Monroe Monroe, Michigan  48162
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Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
St. Anthony's Memorial Hospital Effingham, Illinois  62401
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Reid Hospital & Health Care Services Richmond, Indiana  47374
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Flower Hospital Cancer Center Sylvania, Ohio  43560
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Mercy Hospital at Wilkes-Barre Wilkes-Barre, Pennsylvania  18765