Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
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
3 other identifiers
interventional
1,286
28 countries
274
Brief Summary
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2003
Longer than P75 for phase_3
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2003
CompletedFirst Posted
Study publicly available on registry
November 26, 2003
CompletedStudy Start
First participant enrolled
December 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2008
CompletedResults Posted
Study results publicly available
May 17, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2018
CompletedFebruary 24, 2021
February 1, 2021
4.5 years
November 24, 2003
April 19, 2012
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months
Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator
PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary Outcomes (31)
Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
PFS in Participants in the ITT Population as Assessed by the Investigator
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Overall Survival in the HER2-Positive Population
From date of randomization until date of death due to any cause, assessed up to 46 months
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Up to 46 months
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Up to 46 months
- +26 more secondary outcomes
Study Arms (2)
Placebo + Letrozole 2.5 mg
PLACEBO COMPARATORLetrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)
Lapatinib 1500 mg + Letrozole 2.5 mg
EXPERIMENTALLapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent;
- Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;
- Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
- If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.
- Tumors that were ER+ and/or PgR+;
- Post-menopausal female subjects ≥ 18 years of age.
- ECOG Performance Status of 0 or 1;
- Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
- Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (\>12 months) to the first dose of randomized therapy.
- Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.
You may not qualify if:
- 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 was allowed; however, treatment was to 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, was not permitted;
- Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
- Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)
- Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (278)
Novartis Investigative Site
Tucson, Arizona, 85715, United States
Novartis Investigative Site
Hot Springs, Arkansas, 71913, United States
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Jonesboro, Arkansas, 72401, United States
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Alhambra, California, 91801, United States
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Bakersfield, California, 93309, United States
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Duarte, California, 91010, United States
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Fountain Valley, California, 92708, United States
Novartis Investigative Site
Fresno, California, 93710, United States
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Fullerton, California, 92835, United States
Novartis Investigative Site
La Jolla, California, 92093-0987, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90095, United States
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Montebello, California, 90640, United States
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Northridge, California, 91325, United States
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Oxnard, California, 93030, United States
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Pleasant Hill, California, 94523, United States
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Porterville, California, 93257, United States
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Redondo Beach, California, 90277, United States
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San Diego, California, 92120, United States
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Santa Barbara, California, 93105, United States
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Santa Maria, California, 93454, United States
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Vallejo, California, 94589, United States
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Vista, California, 92081, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80220, United States
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Longmont, Colorado, 80501, United States
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Wheat Ridge, Colorado, 80033, United States
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New Haven, Connecticut, 06520, United States
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Boca Raton, Florida, 33428, United States
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Boca Raton, Florida, 33486, United States
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Gainesville, Florida, 32605, United States
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Gainesville, Florida, 32610, United States
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Hollywood, Florida, 33021, United States
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Lakeland, Florida, 33805, United States
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Miami, Florida, 33136, United States
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Orlando, Florida, 32804, United States
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Port Saint Lucie, Florida, 34952, United States
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West Palm Beach, Florida, 33401, United States
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Atlanta, Georgia, 30341, United States
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Marietta, Georgia, 30060, United States
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Savannah, Georgia, 31406, United States
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Peoria, Illinois, 61615, United States
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Skokie, Illinois, 60076, United States
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Indianapolis, Indiana, 46202, United States
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Bettendorf, Iowa, 52722, United States
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Louisville, Kentucky, 40202, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70121, United States
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Worcester, Massachusetts, 01608, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55407-3799, United States
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Robbinsdale, Minnesota, 55422, United States
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Saint Louis Park, Minnesota, 55426, United States
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Saint Charles, Missouri, 63304, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89169, United States
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Voorhees Township, New Jersey, 08043, United States
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Santa Fe, New Mexico, 87505, United States
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Manhasset, New York, 11030, United States
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Rochester, New York, 14623, United States
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Chapel Hill, North Carolina, 27599-7305, United States
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Greenville, North Carolina, 27834, United States
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Fargo, North Dakota, 58103, United States
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Canton, Ohio, 44718, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15212, United States
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West Columbia, South Carolina, 29210, United States
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Germantown, Tennessee, 38138, United States
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Knoxville, Tennessee, 37916, United States
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Amarillo, Texas, 79106, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390-9113, United States
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Houston, Texas, 77025, United States
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Irving, Texas, 75061, United States
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Ogden, Utah, 84403, United States
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Salt Lake City, Utah, 84106, United States
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Burlington, Vermont, 05401, United States
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Danville, Virginia, 24541, United States
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Richmond, Virginia, 23230, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Charleston, West Virginia, 25304, United States
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Capital Federal, Buenos Aires, C1426ANZ, Argentina
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Buenos Aires, 1425, Argentina
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Buenos Aires, C1405BWU, Argentina
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Garran, Australian Capital Territory, 2606, Australia
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Douglas, Queensland, 4814, Australia
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Herston, Queensland, 4029, Australia
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Redcliffe, Queensland, 4020, Australia
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Adelaide, South Australia, 5000, Australia
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Salvador, Estado de Bahia, 41825-010, Brazil
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Rio de Janeiro, 20560-120, Brazil
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Plovdiv, 4000, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1756, Bulgaria
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Winnipeg, Manitoba, R2H 2A6, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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London, Ontario, N6A 4L6, Canada
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Mississauga, Ontario, L5B 1B8, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M6R 1B5, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1S 4L8, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Santiago, Región Metro de Santiago, 7500921, Chile
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Santiago, Región Metro de Santiago, 7591046, Chile
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Bogotá, Colombia
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Osijek, 31000, Croatia
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Pula, 52100, Croatia
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Split, 21000, Croatia
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Brno, 656 53, Czechia
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České Budějovice, 370 87, Czechia
Novartis Investigative Site
Prague, 180 00, Czechia
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Aalborg, 9000, Denmark
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Hillerød, 3400, Denmark
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Koebenhavn Oe, 2100, Denmark
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Næstved, 4700, Denmark
Novartis Investigative Site
Odense C, 5000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Angers, 49033, France
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Besançon, 25030, France
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Grenoble, 38043, France
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Lille, 59020, France
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Montpellier, 34298, France
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Paris, 75248, France
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Pierre-Bénite, 69495, France
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Toulouse Cedex9, 31059, France
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Villejuif, 94805, France
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Aalen, Baden-Wurttemberg, 73428, Germany
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Heidelberg, Baden-Wurttemberg, 69115, Germany
Novartis Investigative Site
Heidenheim, Baden-Wurttemberg, 89518, Germany
Novartis Investigative Site
Schwetzingen, Baden-Wurttemberg, 68723, Germany
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, 70174, Germany
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Ulm, Baden-Wurttemberg, 89075, Germany
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Augsburg, Bavaria, 86150, Germany
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Bayreuth, Bavaria, 95445, Germany
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Erlangen, Bavaria, 91054, Germany
Novartis Investigative Site
Munich, Bavaria, 80335, Germany
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Munich, Bavaria, 80637, Germany
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Munich, Bavaria, 81377, Germany
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Regensburg, Bavaria, 93049, Germany
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Rehling, Bavaria, 86508, Germany
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Rosenheim, Bavaria, 83002, Germany
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Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, 60596, Germany
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Wiesbaden, Hesse, 65191, Germany
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Wiesbaden, Hesse, 65199, Germany
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Goslar, Lower Saxony, 38642, Germany
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Leer, Lower Saxony, 26789, Germany
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Bonn, North Rhine-Westphalia, 53127, Germany
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Coesfeld, North Rhine-Westphalia, 48653, Germany
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Düsseldorf, North Rhine-Westphalia, 40217, Germany
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Ibbenbueren, North Rhine-Westphalia, 49477, Germany
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Münster, North Rhine-Westphalia, 48149, Germany
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Troisdorf, North Rhine-Westphalia, 53840, Germany
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Velbert, North Rhine-Westphalia, 42551, Germany
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Altenkirchen, Rhineland-Palatinate, 57610, Germany
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Chemnitz, Saxony, 09009, Germany
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Dresden, Saxony, 01219, Germany
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Kiel, Schleswig-Holstein, 24103, Germany
Novartis Investigative Site
Kiel, Schleswig-Holstein, 24105, Germany
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Pinneberg, Schleswig-Holstein, 25421, Germany
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Jena, Thuringia, 07743, Germany
Novartis Investigative Site
Berlin, 10117, Germany
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Berlin, 10317, Germany
Novartis Investigative Site
Berlin, 12200, Germany
Novartis Investigative Site
Berlin, 14195, Germany
Novartis Investigative Site
Hamburg, 20095, Germany
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Hamburg, 20259, Germany
Novartis Investigative Site
Hamburg, 22081, Germany
Novartis Investigative Site
Hamburg, 22457, Germany
Novartis Investigative Site
Hamburg, 22767, Germany
Novartis Investigative Site
Budapest, 1032, Hungary
Novartis Investigative Site
Budapest, 1088, Hungary
Novartis Investigative Site
Budapest, 1096, Hungary
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Kecskemét, 6000, Hungary
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Kistarcsa, 2143, Hungary
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Szeged, 6720, Hungary
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Tatabánya, 2800, Hungary
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Cork, Ireland
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Dooradoyle, Ireland
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Dublin, 4, Ireland
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Dublin, 8, Ireland
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Dublin, 9, Ireland
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Galway, Ireland
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Tallaght, Dublin, 24, Ireland
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Wilton, Cork, Ireland
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Bologna, Emilia-Romagna, 40138, Italy
Novartis Investigative Site
Parma, Emilia-Romagna, 43100, Italy
Novartis Investigative Site
Rome, Lazio, 00133, Italy
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Rome, Lazio, 00152, Italy
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Genoa, Liguria, 16128, Italy
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Genoa, Liguria, 16132, Italy
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Crema, Lombardy, 26013, Italy
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Milan, Lombardy, 20162, Italy
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Acapulco de Juárez, Guerrero, 39670, Mexico
Novartis Investigative Site
Colima, 28010, Mexico
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Durango, 34000, Mexico
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Durango, 34079, Mexico
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Mexico City, 14050, Mexico
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Amersfoort, 3813 TZ, Netherlands
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Delft, 2625 AD, Netherlands
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Doetinchem, 7009 BL, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Heerlen, 6419 PC, Netherlands
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Leidschendam, 2262 BA, Netherlands
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Maastricht, 6229 HX, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Sittard-geleen, 6162 BG, Netherlands
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The Hague, 2512 VA, Netherlands
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The Hague, 2545 CH, Netherlands
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Utrecht, 3582 KE, Netherlands
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Utrecht, 3584 CX, Netherlands
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Christchurch, 8001, New Zealand
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Lahore, 54000, Pakistan
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Lahore, Pakistan
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Rawalpindi, 46000, Pakistan
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Callao, Callao 2, Peru
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Lima, Lima 34, Peru
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Bydogoszcz, 85-796, Poland
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Krakow, 31-115, Poland
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Poznan, 61-866, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Moscow, 107005, Russia
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Moscow, 115 478, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Capital Park, 0002, South Africa
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Panorama, 7500, South Africa
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Parktown, 2193, South Africa
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Port Elizabeth, 6001, South Africa
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Gyeonggi-do, 411-769, South Korea
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Seodaemun-gu, Seoul, 03722, South Korea
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Seoul, 135-710, South Korea
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Alcala de Henares (Madrid), Spain
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Badalona, 08916, Spain
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Barcelona, 08036, Spain
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Donostia / San Sebastian, 20014, Spain
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Elche, 03203, Spain
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Girona, 17007, Spain
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Leganes, Madrid, 28911, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28035, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Móstoles, 28935, Spain
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Oviedo, 33006, Spain
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Palma de Mallorca, 07010, Spain
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Valencia, 46010, Spain
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Vigo ( Pontevedra), 36204, Spain
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Zaragoza, 50009, Spain
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Sfax, 3000, Tunisia
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Sousse, 4000, Tunisia
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Tunis, 1004, Tunisia
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Tunis, 1007, Tunisia
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Ankara, 06100, Turkey (Türkiye)
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Istanbul, 34865, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Chelmsford, Essex, CM1 7ET, United Kingdom
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Manchester, Lancashire, M20 4BX, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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Sutton, Surrey, SM2 5PT, United Kingdom
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Birmingham, West Midlands, B18 7QH, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW17 0QT, United Kingdom
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London, SW3 6JJ, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
Related Publications (6)
Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.
PMID: 19786658BACKGROUNDSchwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15.
PMID: 20156908BACKGROUNDSherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26.
PMID: 20798196BACKGROUNDFinn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6.
PMID: 24198242BACKGROUNDPrat A, Cheang MC, Galvan P, Nuciforo P, Pare L, Adamo B, Munoz M, Viladot M, Press MF, Gagnon R, Ellis C, Johnston S. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. 2016 Oct 1;2(10):1287-1294. doi: 10.1001/jamaoncol.2016.0922.
PMID: 27281556BACKGROUNDWedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
PMID: 29522361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2003
First Posted
November 26, 2003
Study Start
December 9, 2003
Primary Completion
June 3, 2008
Study Completion
March 22, 2018
Last Updated
February 24, 2021
Results First Posted
May 17, 2012
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com