Study Comparing GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/6/2018
Start Date:December 9, 2003
End Date:March 22, 2018

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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor-Positive Advanced or Metastatic Breast Cancer

This study will compare the efficacy and tolerability of GW572016 administered in combination
with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive
advanced or metastatic breast cancer.


Inclusion Criteria:

- Signed informed consent;

- Subjects must have histologically confirmed invasive breast cancer with stage IV
disease at primary diagnosis or at relapse after curative-intent surgery [Singletary,
2002];

- Tumors that are ER+ and/or PgR+;

- Subjects will be considered ER+ or PgR+ if any assay [cytochemical, immunochemical,
immunohistochemistry (IHC), or radioimmunoassay] of primary or secondary tumor tissue
is positive;

- Post-menopausal female subjects =18 years of age;

- ECOG Performance Status of 0 or 1;

- Subjects must have archived tumor tissue available to compare tumor response with
intra-tumoral expression of ErbB1 and ErbB2. Archived tumor tissue will also be used
to confirm estrogen receptor (ER) and/or progesterone receptor (PgR) positivity.
Results will not be used to determine subject eligibility for the study;

- Adjuvant therapy with an aromatase inhibitor is allowed; however, treatment must have
ended more than 1 year prior (>12 months) to the first dose of randomized therapy;

- Adjuvant therapy with trastuzumab is allowed; however, treatment must have ended more
than 1 year prior (>12 months) to the first dose of randomized therapy;

- Subjects who received neo-adjuvant/adjuvant therapy and now present with newly
relapsed advanced or metastatic disease are eligible; however, prior
neo-adjuvant/adjuvant therapy is not required for study entry; 11. Subjects must have
ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP,
[Premarin]), at least 1 month (30 days) prior to receiving the first dose of
randomized therapy;

- Radiotherapy prior to initiation of randomized therapy is allowed to a limited area
(e.g., palliative treatment for painful bone metastases), if it is not the sole site
of disease. Subject must have completed treatment and recovered from all treatment
related toxicities, in particular bone marrow suppression;

- Able to swallow and retain oral medication;

- Cardiac ejection fraction within the institutional range of normal as measured by
echocardiogram (or MUGA scan if an echocardiogram cannot be performed or is
inconclusive);

- Subjects must complete all screening assessments as outlined in the protocol;

- Adequate organ function

Exclusion Criteria:

- Pre-menopausal, pregnant, or lactating;

- Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or
anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;

- Bisphosphonate therapy for bone metastases is allowed; however, treatment must be
initiated prior to the first dose of randomized therapy. Prophylactic use of
bisphosphonates in subjects without bone disease, except for the treatment of
osteoporosis, is not permitted;

- Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel. Subjects with ulcerative colitis are also
excluded;

- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible;

- Concurrent disease or condition that would make the subject inappropriate for study
participation, or any serious medical disorder that would interfere with the subject's
safety;

- Subjects who have not recovered from toxicities related to prior adjuvant therapy
(e.g., surgery, radiotherapy, chemotherapy, hormonal therapy, immunotherapy, biologic
therapy, and investigational agents);

- Subjects who have received anthracyclines in the neo-adjuvant and/or adjuvant setting,
which exceeded the following doses: 360 mg/m2 of Doxorubicin, 720 mg/m2 of Epirubicin,
and 72 mg/m2 of Mitoxantrone;

- Subjects with extensive symptomatic visceral disease including hepatic involvement and
pulmonary lymphangitic spread of tumor, or the disease is considered by the
investigator to be rapidly progressing or life threatening;

- Active or uncontrolled infection;

- Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent;

- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart
failure;

- Known history of, or clinical evidence of, central nervous system (CNS) metastases or
leptomeningeal carcinomatosis;

- Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery,
immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or tumor
embolization) other than letrozole;

- Concurrent treatment with an investigational agent or participation in another
clinical trial;

- Used an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of randomized therapy (GW572016 or placebo);

- The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy
to drugs chemically related to randomized therapy (GW572016 or placebo) or to
excipients of randomized therapy (GW572016 or placebo); 18. Subject has known
hypersensitivity to Femara or excipients of Femara
We found this trial at
82
sites
Santa Maria, California 93454
150
mi
from 91732
Santa Maria, CA
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Alhambra, California 91080
6
mi
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Alhambra, CA
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Amarillo, Texas 79106
918
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Amarillo, TX
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Atlanta, Georgia 30322
1922
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Atlanta, GA
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Aurora, Colorado 80010
824
mi
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Aurora, CO
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Bakersfield, California 93301
107
mi
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Bakersfield, CA
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Bettendorf, Iowa 52722
1579
mi
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Bettendorf, IA
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Boca Raton, Florida 33486
2311
mi
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Boca Raton, FL
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Burlington, Vermont 05401
2467
mi
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Burlington, VT
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Canton, Ohio 44718
2044
mi
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Canton, OH
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Capital Federal, Buenos Aires
6113
mi
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Capital Federal,
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Chapel Hill, North Carolina 27599
2194
mi
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Chapel Hill, NC
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Charleston, West Virginia 25304
2035
mi
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Charleston, WV
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Dallas, Texas 75216
1225
mi
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Dallas, TX
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Danville, Virginia 24541
2169
mi
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Danville, VA
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Denver, Colorado 80262
820
mi
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Denver, CO
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Duarte, California 91010
5
mi
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Duarte, CA
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Duluth, Minnesota 55805
1610
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Duluth, MN
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Fargo, North Dakota 58123
1415
mi
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Fargo, ND
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Fountain Valley, California 92708
25
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Fountain Valley, CA
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Fresno, California 93710
213
mi
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Fresno, CA
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Fullerton, California 92835
12
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Fullerton, CA
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Gainesville, Florida 32608
2104
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Gainesville, FL
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Germantown, Tennessee 38138
1600
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Germantown, TN
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Greenville, North Carolina 27834
2290
mi
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Greenville, NC
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Hershey, Pennsylvania 17033
2295
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Hershey, PA
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Hollywood, Florida 33021
2315
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Hollywood, FL
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Hot Springs, Arkansas 71913
1421
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Hot Springs, AR
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Houston, Texas 77030
1357
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Houston, TX
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Indianapolis, Indiana 46202
1792
mi
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Indianapolis, IN
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Irving, Texas 75062
1213
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Irving, TX
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Jonesboro, Arkansas 72401
1546
mi
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Jonesboro, AR
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Knoxville, Tennessee 37934
1923
mi
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Knoxville, TN
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La Jolla, California 92037
95
mi
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La Jolla, CA
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Lakeland, Florida 33805
2163
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Lakeland, FL
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Las Vegas, Nevada 89135
217
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Las Vegas, NV
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Long Beach, California 90813
22
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Long Beach, CA
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Longmont, Colorado 80501
825
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Los Angeles, California 90095
25
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Los Angeles, CA
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Louisville, Kentucky 40202
1812
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Manhasset, New York 11030
2448
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Marietta, Georgia 30060
1908
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Metairie, Louisiana 70006
1647
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Metairie, LA
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Miami, Florida 33136
2321
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Miami, FL
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Minneapolis, Minnesota 55402
1509
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Minneapolis, MN
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Montebello, California 90640
6
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Montebello, CA
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New Haven, Connecticut
2486
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New Orleans, Louisiana 70115
1655
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Northridge, California 91325
30
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Northridge, CA
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Ogden, Utah 84405
590
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Omaha, Nebraska 68144
1291
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Orlando, Florida 32806
2186
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Oxnard, California 93030
67
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Peoria, Illinois 61615
1616
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Philadelphia, Pennsylvania 19102
2375
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Pittsburgh, Pennsylvania 15224
2121
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Pleasant Hill, California 94523
350
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Port Saint Lucie, Florida 34952
2273
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Porterville, California 93257
148
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Redondo Beach, California 90277
27
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Richmond, Virginia 23249
2267
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Robbinsdale, Minnesota 55422
1508
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Rochester, New York 14615
2244
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Rochester, NY
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Saint Charles, Missouri 63301
1558
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Saint Louis, Missouri 63128
1562
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Saint Louis Park, Minnesota 55416
1505
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Salt Lake City, Utah 84103
570
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Salt Lake City, UT
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San Diego, California 92123
100
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Santa Barbara, California 93108
99
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Santa Fe, New Mexico 87505
692
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Savannah, Georgia 31406
2132
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Seattle, Washington 98103
965
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Skokie, Illinois 60077
1724
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Skokie, IL
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Tacoma, Washington 98405
939
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Tacoma, WA
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Tucson, Arizona 85745
417
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Tucson, AZ
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Vallejo, California 94589
365
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Vallejo, CA
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Vista, California 92083
74
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Vista, CA
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Voorhees, New Jersey 08043
2386
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Voorhees, NJ
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West Columbia, South Carolina 29169
2103
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West Palm Beach, Florida 33407
2300
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Wheat Ridge, Colorado 80033
813
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Wheat Ridge, CO
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Worcester, Massachusetts 01665
2540
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Worcester, MA
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