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Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women With Hormone Receptor-Positive Advanced Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women With Hormone Receptor-Positive Advanced Breast Cancer


I. To compare the progression-free survival of women with estrogen- and/or
progesterone-receptor-positive stage IIIB-IV breast cancer treated with letrozole with vs
without bevacizumab as first-line treatment.


I. To compare the proportion of patients receiving letrozole with or without bevacizumab who
remain progression-free at 6 and 12 months.

II. To compare the incidence of objective response (complete response [CR] + partial
response [PR]) in patients receiving letrozole with or without bevacizumab, as determined by
RECIST criteria, excluding patients with non-measurable disease.

III. To compare the incidence of clinical benefit (CR + PR + stable disease >= 6 months) in
patients receiving letrozole with or without bevacizumab.

IV. To compare the duration of objective response in patients receiving letrozole with or
without bevacizumab.

V. To compare the time to treatment failure, defined as the interval from randomization
until progression, toxicity, withdrawn consent, or going onto non protocol therapy, in
patients receiving letrozole with or without bevacizumab.

VI. To compare the overall survival of patients receiving letrozole with or without
bevacizumab, including the probability of survival until 36 months.

V. To compare toxicity levels of bevacizumab in both the letrozole-treated patients and in
the tamoxifen-treated* patients.

VI. To compare progression-free survival and overall survival of all patients receiving
endocrine therapy with and without bevacizumab (by combining both letrozole and tamoxifen*
patient subgroups). NOTE: *As of 5/15/2011, patients only receive letrozole.

OUTLINE: This is a multicenter study. Patients are stratified according to planned endocrine
therapy* (letrozole vs tamoxifen*), disease measurability (no vs yes), and disease-free
interval from initial diagnosis to first progression (≤ 24 months vs > 24 months). Patients
are randomized to 1 of 2 treatment arms.

NOTE: The placebo-controlled portion of the study was canceled on 5-15-10

ARM I: Patients receive oral endocrine therapy* (tamoxifen citrate or letrozole) once daily
on days 1-21 and bevacizumab IV on day 1. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.

ARM II: Patients receive oral endocrine therapy* (tamoxifen citrate or letrozole) once daily
on days 1-21. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed up every 6 months for the first 2
years and then annually for up to 3 years.

NOTE: As of 5/15/2011, patients only receive letrozole.

Inclusion Criteria:

- Histologic confirmation of invasive cancer of the female breast in either the primary
or metastatic setting

- Stage IIIB disease not amenable to local therapy or stage IV disease

- Must have measurable or nonmeasurable disease by RECIST criteria, with radiologic
scans (CT scan of the chest/abdomen)

- Measurable disease is defined as lesions that can be accurately measured in at
least one dimension (longest diameter to be recorded) as ≥ 2.0 cm with
conventional techniques or as ≥ 1.0 cm with spiral CT scan

- Nonmeasurable disease is defined as all other lesions, including small lesions
(longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral
CT scan) and truly nonmeasurable lesions, including any of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Baseline bone scans required for all patients for determination of metastatic bone

- CT scan with bone windows required only for patients with bone metastases as the
only site of disease

- No known CNS metastases or leptomeningeal disease(screening with brain imaging is not
required for asymptomatic patients)

- Hormone receptor status: tumors (from either primary or metastatic sites) must
express estrogen receptor (ER)and/or progesterone receptor (PgR) in ≥ 1% of cells

- Menopausal status: pre- or postmenopausal, meeting 1 of the following criteria:

- Age ≥ 55 years and one year or more of amenorrhea

- Age < 55 years and one year or more of amenorrhea, with an estradiol assay <

- Age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay <
20 pg/ml

- Surgical menopause with bilateral oophorectomy

- Ovarian suppression on a luteinizing hormone-releasing hormone agonist
(goserelin acetate or leuprolide acetate)

- Premenopausal women must undergo ovarian suppression prior to beginning
protocol therapy

- Ovarian radiation is not permitted for induction of ovarian

- ECOG (Zubrod) performance status 0-1

- Life expectancy ≥ 12 weeks

- Granulocytes ≥ 1,000/μl

- Platelet count ≥ 100,000/μl

- Creatinine ≤ 2.0 mg/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) unless due to Gilbert's syndrome

- Transaminases (ALT, AST) ≤ 2.5 times ULN

- INR ≤ 1.6 unless on full dose warfarin

- Urinalysis ≤ 1+ protein

- Proteinuria ≥ 2 + at baseline must demonstrate < 1 g of protein/24 hr or
protein:creatinine ratio < 1 on 24-hoururine collection

- No "currently active" second malignancy other than nonmelanoma skin cancers

- Patients are not considered to have a "currently active" malignancy if they have
completed therapy and are considered by their physician to be at less than 30%
risk of relapse

- Taxane-related neurotoxicity must have resolved to sensory grade < 2

- No motor neuropathy of any grade

- No significant traumatic injury within 28 days prior to study registration

- No history of abdominal fistula, or intra-abdominal abscess within the past 6 months

- No history of GI perforation within the past 12 months

- No history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI
bleeding) within the past 6 months

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

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
and/or diastolic BP > 90 mm Hg on antihypertensive medications

- Prior history of hypertensive crisis or hypertensive encephalopathy

- Myocardial infarction or unstable angina within past 6 months

- New York Heart Association class II-IV congestive heart failure

- Symptomatic peripheral vascular disease

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Significant arterial thrombotic events

- No history of stroke or transient ischemic attack within the past 6 months

- History of seizures must be well controlled with standard medication

- No known allergies to imidazole drugs, (e.g., clotrimazole, ketoconazole, miconazole,
econazole, sulconazole, ticonazole, or terconazole) or compounds structurally similar
to bevacizumab (for patients treated with aromatase inhibitors)

- No known allergies to selective estrogen receptor modulators (e.g., tamoxifen,
raloxifene, or toremifene) or compounds structurally similar to bevacizumab (for
patients treated with tamoxifen) NOTE: As of 5/15/2011, patients only receive

- No serious, non-healing wound, ulcer, or bone fracture

- Not pregnant or nursing

- Negative pregnancy test

- No prior endocrine therapy in the metastatic setting unless tamoxifen or an aromatase
inhibitor was initiated within 4 weeks prior to registration

- If prior endocrine therapy was initiated within the past 4 weeks, the patients
should remain on that chosen hormonal therapy (tamoxifen or aromatase inhibitor)
as the study therapy. NOTE: As of 5/15/2011, patients only receive letrozole.

- Patients who began therapy with tamoxifen (after 5/15/2011), anastrozole or
exemestane must switch to letrozole

- Prior endocrine therapy in the adjuvant setting allowed

- Prior treatment with ovarian suppression is allowed in either the adjuvant or
metastatic setting

- If medical ovarian suppression is being administered it can be initiated any
time prior to or at the start of protocol therapy, and continued throughout the
duration of the trial

- At least 28 days since surgical castration with bilateral oophorectomy

- At least 2 weeks since prior radiotherapy and all toxicities resolved

- At least 12 months since the completion of prior adjuvant or neoadjuvant chemotherapy
and all toxicities must have resolved

- No prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy

- May have received 1 prior chemotherapy regimen for metastatic disease

- More than 28 days since prior major surgical procedure or open biopsy and fully
recovered from any such procedure

- No core biopsy or other minor surgical procedure (except placement of a vascular
access device) within 7 days prior to study registration

- Prior palliative irradiation of a symptomatic lesion, or one that may produce
disability (e.g., unstable femur) prior to study initiation, provided other
measurable or non-measurable disease is present, is allowed

- Palliative radiotherapy may not be administered during protocol therapy

- Must not have anticipation of need for major surgical procedure during the course of
the study

- Concurrent full-dose anticoagulation therapy is allowed for the treatment of prior
conditions such as venous thromboses or atrial fibrillation, but not for the
treatment of prior arterial thrombotic events

- Patients on full-dose anticoagulants must be on a stable dose of warfarin and
have an in-range INR (usually between 2 and 3) or be on a stable dose flow
molecular weight heparin

- Concurrent antiplatelet agents, daily prophylactic aspirin, or anticoagulation for
atrial fibrillation allowed

- Concurrent treatment with bisphosphonates is allowed and recommended

- No concurrent hormones or other chemotherapeutic agents except for steroids given for
adrenal failure or chronic non-cancer related diseases, hormones administered for
non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of
dexamethasone as an antiemetic in solid tumor protocols

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

From randomization until disease progression or death, assessed up to 3 years

Safety Issue:


Principal Investigator

Maura Dickler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms



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Kinston Medical Specialists PAKinston, North Carolina  28501
Saint Alexius Medical CenterBismarck, North Dakota  58501
Aultman Health FoundationCanton, Ohio  44710
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Saint Rita's Medical CenterLima, Ohio  45801
Marietta Memorial HospitalMarietta, Ohio  45750
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Providence Saint Vincent Medical CenterPortland, Oregon  97225
Columbia River Oncology ProgramPortland, Oregon  97225
Scranton Hematology OncologyScranton, Pennsylvania  18510
Mercy HospitalScranton, Pennsylvania  18501
Hematology and Oncology Associates of Rhode Island IncCranston, Rhode Island  02920
Kent County HospitalWarwick, Rhode Island  02886
AnMed Health HospitalAnderson, South Carolina  29621
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Conklin Regional Cancer CenterAberdeen, South Dakota  57401
Sanford Cancer Center-Oncology ClinicSioux Falls, South Dakota  57104
Wheeling HospitalWheeling, West Virginia  26003
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Vince Lombardi Cancer Clinic-MarinetteMarinette, Wisconsin  54143
Bay Area Medical CenterMarinette, Wisconsin  54143
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Oconomowoc Memorial Hospital-ProHealth Care IncOconomowoc, Wisconsin  53066-3896
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Olathe Cancer CenterOlathe, Kansas  66061
Jupiter Medical CenterJupiter, Florida  33458
Gainesville Hematology Oncology AssociatesGainesville, Florida  32605
Elkhart ClinicElkhart, Indiana  46515
Marin General HospitalGreenbrae, California  94904
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Northeast Georgia Cancer Care LLCAthens, Georgia  30607
Harbin Clinic Medical Oncology and Clinical ResearchRome, Georgia  30165
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
Illinois CancerCare-HavanaHavana, Illinois  62644
Illinois CancerCare-Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare-MacombMacomb, Illinois  61455
Illinois CancerCare-MonmouthMonmouth, Illinois  61462
Illinois CancerCare-Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare-PekinPekin, Illinois  61603
Illinois CancerCare-PeruPeru, Illinois  61354
Illinois CancerCare-PrincetonPrinceton, Illinois  61356
Illinois CancerCare-Spring ValleySpring Valley, Illinois  61362
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Michiana Hematology Oncology PC-NilesNiles, Michigan  49120
Central Care Cancer Center-Carrie J Babb Cancer CenterBolivar, Missouri  65613
Skaggs Cancer CenterBranson, Missouri  65616
University of Missouri - Ellis FischelColumbia, Missouri  65203
Hackensack University Medical CCOPHackensack, New Jersey  07601
Moses Cone Health System-Regional Cancer CenterGreensboro, North Carolina  27403
Annie Penn Memorial HospitalReidsville, North Carolina  27320
Erlanger Medical CenterChattanooga, Tennessee  37403
West Virginia University CharlestonCharleston, West Virginia  25304
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Aurora Advanced Healthcare Inc-MequonMequon, Wisconsin  53092
Medical Consultants LimitedMilwaukee, Wisconsin  53215
Vince Lombardi Cancer Clinic-SheboyganSheboygan, Wisconsin  53081
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Aurora Medical Center in SummitSummit, Wisconsin  53066
Vince Lombardi Cancer ClinicTwo Rivers, Wisconsin  54241
Riverview HospitalWisconsin Rapids, Wisconsin  54494
Kaiser Permanente - Largo Medical CenterLargo, Maryland  20774
Kaiser Permanente - Towson Medical CenterLutherville, Maryland  21093
Kaiser Permanente - Fair Oaks Medical CenterFairfax, Virginia  22033
Spector, David MD (UIA Investigator)Moline, Illinois  61265
Doctors Carrol, Sheth, RaghavanLouisville, Kentucky  40215
Hematology and Oncology ClinicBaton Rouge, Louisiana  70809
Ochsner North Shore Medical CenterCovington, Louisiana  70433
Veterans Administration Medical CenterBaltimore, Maryland  21201
Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
Comprehensive Cancer Care PCSaint Louis, Missouri  63141
Saint Joseph HospitalNashua, New Hampshire  03060
Arnot Ogden Medical CenterElmira, New York  14905
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Saint Charles Medical Center-BendBend, Oregon  97701
Saint Francis HospitalGreenville, South Carolina  29601
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
Sparks Regional Medical CenterFort Smith, Arkansas  72901
Los Angeles County-USC Medical CenterLos Angeles, California  90033
San Francisco General HospitalSan Francisco, California  94110
Eisenhower Army Medical CenterFort Gordon, Georgia  30509
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
The Schiffler Cancer Center of Wheeling HospitalWheeling, West Virginia  26003
Dublin Hematology Oncology Care PCDublin, Georgia  31021
IU Health ArnettLafayette, Indiana  
Georgia Health Sciences UniversityAugusta, Georgia  30912
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California  94704
Boca Raton Regional HospitalBoca Raton, Florida  33486
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PCEast Syracuse, New York  13057
Roy and Patricia Disney Family Cancer CenterBurbank, California  91505
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
Providence Sacred Heart Medical Center and Children's HospitalSpokane, Washington  99204
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
Aurora Cancer Care-BurlingtonBurlington, Wisconsin  53105
Aurora Cancer Care-FranklinFranklin, Wisconsin  53132
Aurora Cancer Care-GlendaleGlendale, Wisconsin  53212
Aurora Cancer Care-Kenosha SouthKenosha, Wisconsin  53142
Aurora Cancer Care-Milwaukee SouthMilwaukee, Wisconsin  53215
Aurora Cancer Care-RacineRacine, Wisconsin  53406-5661
Aurora Cancer Care-WaukeshaWaukesha, Wisconsin  53188
Aurora Cancer Care-Milwaukee WestWauwatosa, Wisconsin  53226
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Springfield Regional Medical CenterSpringfield, Ohio  45505
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702
Guthrie Clinic-Robert Packer HospitalSayre, Pennsylvania  18840
Providence Holy Family HospitalSpokane, Washington  99208
PeaceHealth Southwest Medical CenterVancouver, Washington  98664
Aurora Cancer Care-Southern LakesElkhorn, Wisconsin  53121
Maine Center for Cancer Medicine and Blood Disorders-ScarboroughScarborough, Maine  04074
Saint Vincent's Hospital and Medical Center of New YorkNew York, New York  10011
Ochsner Baptist Medical CenterNew Orleans, Louisiana  70115
Providence Willamette Falls Medical CenterOregon City, Oregon  97045
East Bay Medical Oncology Hematology Medical Associates-AntiochAntioch, California  94531
Diablo Valley Oncology and Hematology Medical Group-Pleasant HillPleasant Hill, California  94523
East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant HillPleasant Hill, California  94523
East Bay Medical Oncology Hematology Associates IncSan Leandro, California  94578
LC Ferguson Cancer CenterFreeport, Illinois  61032
Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalMilford, Massachusetts  01757