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Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer


- Compare the time to tumor progression in postmenopausal women with metastatic breast
cancer treated with anastrozole with or without fulvestrant as first-line therapy.

- Compare the clinical benefit (complete or partial response, confirmed or unconfirmed,
or stable disease ≥ 24 weeks) and overall survival of patients treated with these

- Compare adverse events in patients treated with these regimens.

- Determine the prognostic significance of estrogen receptor positivity and HER2/neu
status in patients treated with these regimens.

- Determine parameters of estrogen and clinical pharmacology and estrogen levels in
patients treated with these regimens.

- Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these
regimens (closed as of 4/16/2009).

- Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these
regimens (closed as of 4/16/2009).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral anastrozole once daily on days 1-28.

- Arm II: Patients receive oral anastrozole as in arm I. Patients also receive
fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of
the subsequent courses.

In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

Patients are followed for up to 4 years.

PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


- Histologically confirmed breast cancer meeting 1 of the following criteria:

- Metastatic disease (M1)

- Multiple sites of new disease that is clinically obvious metastatic disease
(e.g., multiple sites of new osseous disease)

- Measurable or nonmeasurable disease

- No known brain or CNS metastases

- Hormone receptor status:

- Estrogen-receptor positive* AND/OR

- Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of
> 10 fmol/mg cytosol protein by ligand binding assay or positive by



- Not specified


- Female

Menopausal status

- Postmenopausal, as defined by 1 of the following:

- Prior bilateral oophorectomy

- More than 12 months since last menstrual period with no prior hysterectomy

- At least 55 years of age with prior hysterectomy

- Under 55 years of age with a prior hysterectomy without oophorectomy and with
estradiol and follicle-stimulating hormone levels consistent with menopause

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting
factor deficiency)


- INR ≤ 1.6


- Not specified


- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission


Biologic therapy

- No prior immunotherapy for recurrent or metastatic disease


- No prior chemotherapy for recurrent or metastatic disease

- More than 12 months since prior adjuvant or neoadjuvant chemotherapy

- No concurrent chemotherapy for malignancy

Endocrine therapy

- Prior adjuvant hormonal therapy allowed

- At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH)

- Menstrual periods must not have resumed since LHRH therapy

- More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g.,
anastrozole, letrozole, or exemestane)

- More than 12 months since prior fulvestrant

- No prior hormonal therapy for recurrent or metastatic disease

- No other concurrent hormonal therapy for malignancy

- No concurrent hormone replacement therapy


- Not specified


- Not specified


- No long-term anticoagulant therapy (except antiplatelet therapy)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to tumor progression

Outcome Time Frame:

13 months

Safety Issue:


Principal Investigator

Rita S. Mehta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

October 2013

Related Keywords:

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



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Medical Consultants, Limited Milwaukee, Wisconsin  53215
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Kinston Medical Specialists Kinston, North Carolina  28501
Glendale Memorial Hospital Comprehensive Cancer Center Glendale, California  91204
Resurrection Medical Center Chicago, Illinois  60631
Sherman Hospital Elgin, Illinois  60120-2198
Freeman Cancer Institute at Freeman Health System Joplin, Missouri  64803-2644
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Highlands Oncology Group - Springdale Springdale, Arkansas  72764
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Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
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Guardian Oncology and Center for Wellness Missoula, Montana  59804
Lakes Region General Hospital Laconia, New Hampshire  03246
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Rockwood Clinic Cancer Treatment Center Spokane, Washington  99204-2967
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center Dubois, Pennsylvania  15801
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
University of Tennessee Cancer Institute - Memphis Memphis, Tennessee  38104
Independence Regional Health Center Independence, Missouri  64050
Parvin Radiation Oncology Kansas City, Missouri  64116
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville, California  95901
Tahoe Forest Cancer Center Truckee, California  96161
York Hospital's Oncology Treatment Center York, Maine  03909
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997
Mercy General Health Partners Muskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Trinity CancerCare Center Minot, North Dakota  58701
Bay Area Hospital Coos Bay, Oregon  97420
AnMed Cancer Center Anderson, South Carolina  29621
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Providence Cancer Center at PMCC Medford, Oregon  97504
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Regional Medical Center Anniston, Alabama  36202
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs, Colorado  80909
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
Heartland Oncology and Hematology Council Bluffs, Iowa  51503
Mercy Regional Cancer Center Janesville, Wisconsin  53547
Central Maine Comprehensive Cancer Center at Central Maine Medical Center Lewiston, Maine  04240
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus Boca Raton, Florida  33486
Portneuf Cancer Center at Portneuf Medical Center Pocatello, Idaho  83201
Caritas Holy Family Hospital Methuen, Massachusetts  01844
Union State Bank Cancer Center at Nyack Hospital Nyack, New York  10960-1998
Hudson Valley Oncology Associates Poughkeepsie, New York  12601
Clarian Arnett Cancer Care Lafayette, Indiana  47904
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Cooperstown, New York  13326
Shaw Regional Cancer Center Edwards, Colorado  81632
Valley View Hospital Cancer Center Glenwood Springs, Colorado  81601
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Albuquerque, New Mexico  87110
Cleveland Clinic Beachwood Family Health and Surgery Center Beachwood, Ohio  44122
Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids, Wisconsin  54494
North Broward Medical Center Dearfield Beach, Florida  33064-3596
Northeast Georgia Cancer Care, LLC - Medical Oncology Athens, Georgia  30607
St. Francis Regional Cancer Center Trenton, New Jersey  08629
Capital Health Regional Cancer Center Trenton, New Jersey  08618
St. Vincent Cancer Center at St. Vincent Regional Medical Center Santa Fe, New Mexico  87505
Cancer Center of Poughkeepsie Poughkeepsie, New York  12601
Dyson Center for Cancer Care at Vassar Brothers Medical Center Poughkeepsie, New York  12601-3990
Mabry Center for Cancer Care at Regional Medical Center Orangeburg, South Carolina  29118