Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	CALGB-40302 NCT00390455

Objectives

Primary

1. Compare the progression-free survival of postmenopausal women with stage III or IV hormone receptor-positive breast cancer treated with fulvestrant with or without lapatinib ditosylate.

Secondary

• Compare the response rate in patients treated with these regimens.
• Compare response and stable disease rate (i.e., complete response, partial response, and stable disease > 6 months) in patients treated with these regimens.
• Compare the duration of response in patients treated with these regimens.
• Compare the overall survival of patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically* or cytologically confirmed breast cancer, meeting 1 of the following stage criteria:
  • Stage III (locally advanced) disease not considered amenable to curative therapy
  • Stage IV (primary or metastatic) disease

   [Note: *Histological documentation of recurrent/metastatic disease is not required if there is clinical evidence of recurrence]

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
  • Lytic or blastic bone metastases as only site of disease allowed
  • The following are not considered measurable disease:
    • Bone lesions (except as above)
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast cancer
    • Lymphangitis cutis/pulmonitis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions
• Must have received prior therapy with 1 or 2 endocrine treatments for breast cancer in either the adjuvant or metastatic setting (not including treatment for ovarian suppression or amenorrhea)
  • Tumor must be potentially sensitive to endocrine therapy, defined as ≥ 3 months of prior endocrine therapy without disease progression in the adjuvant or metastatic setting
  • Treatments must have been commercially-available third-generation aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole)*

   [Note: *Sequential use of 2 different third-generation aromatase inhibitors is considered 1 prior treatment; it is not required that tumors be resistant to this treatment]

• No symptomatic brain or other CNS metastases
  • Previously treated brain metastases allowed provided patient is free of symptoms AND > 3 months since prior treatment for brain metastases
• Hormone receptor status:
  • Estrogen receptor- and/or progesterone receptor-positive tumor by IHC methods (≥ 1% cells considered positive)

Prior/Concurrent Therapy:

• See Disease Characteristics
• At least 2 weeks since prior chemotherapy and recovered
  • Prior chemotherapy in the adjuvant and/or neoadjuvant setting allowed
  • No more than 1 prior chemotherapy regimen for stage IV breast cancer
• At least 3 weeks since prior trastuzumab (Herceptin®) and recovered
  • Prior trastuzumab in the adjuvant and/or neoadjuvant setting allowed
  • No prior trastuzumab for stage IV breast cancer
• No prior fulvestrant
• No prior epidermal growth factor receptor (EGFR) inhibitors (e.g., gefitinib, erlotinib hydrochloride, lapatinib ditosylate, or cetuximab)
• No other prior or concurrent experimental EGFR inhibitors
• No other concurrent chemotherapy
• No concurrent radiotherapy, including palliative radiotherapy
• No other concurrent hormonal therapy* except for the following:
  • Steroids for adrenal failure
  • Hormones for nondisease-related conditions (e.g., insulin for diabetes or synthroid for hypothyroidism)
  • Intermittent dexamethasone as an antiemetic
• No concurrent therapeutic systemic anticoagulation (defined as maintaining INR > 1.6)
  • Low-dose warfarin or acetylsalicylic acid (or equivalent) for maintenance of central venous catheter patency allowed
• No other concurrent endocrine therapy, including systemic hormone-replacement therapy or intravaginal estrogen
• Prior initiation of and concurrent bisphosphonate therapy allowed

 [Note: *Patients receiving a gonadotropin-releasing hormone agonist for ovarian suppression must remain on therapy throughout the course of study treatment]

Patient Characteristics:

• Female
• Postmenopausal, meeting 1 of the following criteria:
  • Age ≥ 60 years
  • Age ≥ 45 years with an intact uterus and amenorrhea for ≥ 12 months
  • History of bilateral oophorectomy
  • Follicle-stimulating hormone levels within postmenopausal range
  • Undergoing treatment with a gonadotropin-releasing hormone agonist for ovarian suppression for ≥ 3 consecutive months prior to study entry, and remains on such therapy throughout study treatment
• Life expectancy > 3 months
• ECOG performance status 0-2
• Granulocyte count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert’s syndrome)
• Creatinine ≤ 2.0 mg/dL
• AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with liver metastases)
• INR ≤ 1.6
• LVEF normal
• Not pregnant or nursing
• Negative pregnancy test
• No pending visceral crisis
• No acquired or inherited bleeding disorder

Expected Enrollment

A total of 324 patients will be accrued for this study.

Outcomes

Progression-free survival

Treatment-related toxicity
Objective tumor response as defined by RECIST criteria (for patients with measurable disease)
Duration of tumor response
Overall survival
Quality of life as measured by the Memorial Symptom Assessment Scale

Outline

This is a multicenter, open-label, randomized, double-blind, placebo-controlled study. Patients are stratified according to prior tamoxifen citrate therapy (yes vs no) and bone disease only (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral lapatinib ditosylate once daily on days 1-28 and fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of each subsequent course.
• Arm II: Patients receive oral placebo once daily on days 1-28 and fulvestrant as in arm I.

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

Quality of life is assessed at baseline and then on day 1 of every 2 courses of treatment (i.e., day 1 of courses 3, 5, 7, etc.).

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Harold J. Burstein, MD, PhD, Protocol chair		Ph: 617-632-3800; 866-790-4500 Email: hburstein@partners.org

U.S.A.
California
	Arroyo Grande
	Arroyo Grande Community Hospital
		David Palchak, MD	Ph:  805-773-7127
	Castro Valley
	East Bay Radiation Oncology Center
		James Feusner, MD	Ph:  510-428-3689
	Eden Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Castro Valley
		James Feusner, MD	Ph:  510-428-3689
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	Mountain View
	El Camino Hospital Cancer Center
		Clinical Trials Office - El Camino Hospital Cancer Center	Ph:  650-988-7623
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus	Ph:  510-204-1414
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Highland General Hospital
		James Feusner, MD	Ph:  510-428-3689
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Pleasanton
	Valley Care Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Pleasanton
		James Feusner, MD	Ph:  510-428-3689
	Salinas
	Salinas Valley Memorial Hospital
		Shehzad Aziz, MD	Ph:  831-755-1701
	San Diego
	Kaiser Permanente Medical Office -Vandever Medical Office
		Han Koh	Ph:  619-528-2596
	San Francisco
	San Francisco General Hospital Medical Center
		Judith Luce, MD	Ph:  415-476-4082ext.414
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
Connecticut
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
District of Columbia
	Washington
	Sibley Memorial Hospital
		Frederick Smith, MD	Ph:  301-657-4588
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Theodore Walters, MD	Ph:  208-381-2711
Illinois
	Kankakee
	Provena St. Mary's Regional Cancer Center - Kankakee
		Riaz Elahi, MD	Ph:  708-873-4500
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Martin Wiesenfeld, MD	Ph:  319-363-8303
	Davenport
	Genesis Medical Center - West Campus
		George Kovach, MD	Ph:  563-421-1960
	Genesis Regional Cancer Center at Genesis Medical Center
		George Kovach, MD	Ph:  563-421-1960
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Louisiana
	Baton Rouge
	Mary Bird Perkins Cancer Center - Baton Rouge
		Robert Veith	Ph:  225-767-0847
	Pennington Cancer Center at Baton Rouge General
		Clinical Trials Office - Pennington Cancer Center at Baton Rouge General	Ph:  225-381-6451
	New Orleans
	MBCCOP - LSU Health Sciences Center
		Robert Veith	Ph:  504-568-5151
	Medical Center of Louisiana - New Orleans
		Robert Veith	Ph:  504-903-2311
Maine
	York
	York Hospital's Oncology Treatment Center
		Jonathan Eneman	Ph:  207-351-3777
Maryland
	Baltimore
	St. Agnes Hospital Cancer Center
		Diana Griffiths	Ph:  410-368-2910
	Easton
	Shore Regional Cancer Center at Memorial Hospital - Easton
		Mary DeShields, MD	Ph:  410-819-3332
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Stephen Grubbs, MD	Ph:  302-366-1200
	Frederick
	Frederick Memorial Hospital Regional Cancer Therapy Center
		Brian O'Connor, MD	Ph:  301-662-8477
Massachusetts
	Boston
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Harold J. Burstein, MD, PhD	Ph:  617-632-3800
	Gloucester
	Addison Gilbert Hospital
		Angus McIntyre, MD	Ph:  978-927-6850
	Lowell
	Lowell General Hospital
		Harold J. Burstein, MD, PhD	Ph:  617-632-3800
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Kathryn Edmiston, MD	Ph:  508-334-5141
Michigan
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Martin Bury	Ph:  616-966-8000
	Big Rapids
	Mecosta County Medical Center
		Martin Bury	Ph:  231-796-8691
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Martin Bury	Ph:  616-391-2799
	CCOP - Grand Rapids
		Martin Bury	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Martin Bury	Ph:  616-752-5222
	Iron Mountain
	Dickinson County Healthcare System
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Traverse City
	Munson Medical Center
		Martin Bury	Ph:  231-935-6202
	Wyoming
	Metro Health Hospital
		Martin Bury	Ph:  616-252-7200
Minnesota
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	St. Luke's Hospital Cancer Care Center
		Tanya Repka, MD, FACP	Ph:  218-726-3081
	Hutchinson
	Hutchinson Area Health Care
		Daniel Anderson	Ph:  320-234-5000 800-454-3903
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Daniel Anderson	Ph:  651-232-7970
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Barbara Craft	Ph:  601-984-5590
	Kessler AFB
	Keesler Air Force Base Medical Center
		Louis Varner	Ph:  228-377-2086
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
	Saint Louis
	Arch Medical Services, Incorporated at Center for Cancer Care and Research
		Alan Lyss, MD	Ph:  314-996-5514
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5514
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Robert Langdon, MD	Ph:  402-399-8762
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-384-0013
New Hampshire
	Concord
	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
		Charles Catcher, MD	Ph:  603-224-2556
	Hooksett
	New Hampshire Oncology - Hematology, PA - Hooksett
		Charles Catcher, MD	Ph:  603-224-2556
	Laconia
	Lakes Region General Hospital
		Charles Catcher, MD	Ph:  603-224-2556
New Jersey
	Livingston
	St. Barnabas Medical Center Cancer Center
		Clinical Trials Office - St. Barnabas Medical Center Cancer Center	Ph:  973-322-2470
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Goldsboro
	Southeastern Medical Oncology Center - Goldsboro
		James Atkins, MD	Ph:  919-580-0000
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Henderson
	Maria Parham Medical Center
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Lumberton
	Southeastern Regional Medical Center
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Oxford
	Granville Medical Center
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Raleigh
	Duke Health Raleigh Hospital
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Roxboro
	Person Memorial Hospital
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Esther Rehmus, MD	Ph:  330-344-6505
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Pennsylvania
	Langhorne
	St. Mary Regional Cancer Center
		Clinical Trials Office - St. Mary Regional Cancer Center	Ph:  215-710-4585
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
Tennessee
	Memphis
	University of Tennessee Cancer Institute - Memphis
		Clinical Trials Office - University of Tennessee Cancer Institute	Ph:  901-448-3303
Vermont
	Berlin
	Mountainview Medical
		Marie Wood, MD	Ph:  802-656-5452
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Washington
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2441
	Kennewick
	Columbia Basin Hematology
		Saul Rivkin, MD	Ph:  206-386-2441
	Seattle
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900
	Minor and James Medical, PLLC
		Saul Rivkin, MD	Ph:  206-386-2441
	Polyclinic First Hill
		Saul Rivkin, MD	Ph:  206-386-2441
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	University Cancer Center at University of Washington Medical Center
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Mary's Hospital Medical Center - Green Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Janesville
	Mercy Regional Cancer Center
		Robert Delaune, MD	Ph:  952-993-1517
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	Dean Medical Center - Madison
		Contact Person	Ph:  608-252-8000 800-844-6015
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Registry Information
Official Title		Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer
Trial Start Date		2006-09-15
Trial Completion Date		2008-12-03 (estimated)
Registered in ClinicalTrials.gov		NCT00390455
Date Submitted to PDQ		2006-09-19
Information Last Verified		2009-11-25
NCI Grant/Contract Number		CA31946

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