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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
N/A
Not Enrolling
Both
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


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 aromatase inhibitor.

Secondary

- 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


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-month progression-free survival (PFS) rate

Safety Issue:

No

Principal Investigator

Winston Tan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000525570

NCT ID:

NCT00423917

Start Date:

August 2007

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Hinsdale, Illinois  60521
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Alexandria, Minnesota  56308
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Flower Hospital Cancer CenterSylvania, Ohio  43560
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Clinton Memorial HospitalWilmington, Ohio  45177
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Galesburg Clinic, PCGalesburg, Illinois  61401
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Mercy Hospital at Wilkes-BarreWilkes-Barre, Pennsylvania  18765