Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00075270
First received: January 7, 2004
Last updated: November 21, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms, Breast |
Drug: Paclitaxel Drug: GW572016 (Lapatinib) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- To evaluate and compare the 2 treatment groups with respect to time to progression (TTP) in subjects with metastatic breast cancer. [ Time Frame: 34 Weeks ]
Secondary Outcome Measures:
- Compare the following data between the 2 treatment groups: Tumor Response Clinical Benefit Time to Response Duration of Response Survival Rate Toxicity Biomarker Signals [ Time Frame: 72 Weeks ]
| Enrollment: | 577 |
| Study Start Date: | January 2004 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks
|
Drug: Paclitaxel
Active Comparator
Drug: GW572016 (Lapatinib)
Oral GW572016 Lapatinib
Other Names:
|
|
Placebo Comparator: Arm 2
Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo
|
Drug: Paclitaxel
Active Comparator
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Signed Informed Consent
- Able to swallow an oral medication
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
- Adequate kidney and liver function
- Adequate bone marrow function
- Tumor tissue available for testing
- Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
- No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
Exclusion criteria:
- Prior treatment regimens for advanced or metastatic breast cancer.
- Pregnant or lactating
- Conditions that would effect the absorption of an oral drug
- Active infection
- Brain metastases
- Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
- Known hypersensitivity to Taxol or excipients of Taxol
- Peripheral neuropathy of Grade 2 or greater is not permitted
- Severe Cardiovascular disease or cardiac disease requiring a device.
- Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075270
Hide Study Locations
Hide Study LocationsLocations
| United States, Arizona | |
| GSK Investigational Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| GSK Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| GSK Investigational Site | |
| La Jolla, California, United States, 92093-0987 | |
| GSK Investigational Site | |
| Vallejo, California, United States, 94589 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| GSK Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32804 | |
| GSK Investigational Site | |
| Port St. Lucie, Florida, United States, 34952 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30341 | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| GSK Investigational Site | |
| Savannah, Georgia, United States, 31405 | |
| GSK Investigational Site | |
| Savannah, Georgia, United States, 31406 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Glen Burnie, Maryland, United States, 21225 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| GSK Investigational Site | |
| Nyack, New York, United States, 10960 | |
| United States, North Dakota | |
| GSK Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97227 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29210 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Knoxville, Tennessee, United States, 37916 | |
| GSK Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| GSK Investigational Site | |
| Amarillo, Texas, United States, 79106 | |
| GSK Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| GSK Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, C1426ANZ | |
| GSK Investigational Site | |
| Buenos Aires, Argentina, 1425 | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Fitzroy, Victoria, Australia, 3065 | |
| GSK Investigational Site | |
| Malvern, Victoria, Australia, 3144 | |
| GSK Investigational Site | |
| Wodonga, Victoria, Australia, 3690 | |
| Australia, Western Australia | |
| GSK Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Belgium | |
| GSK Investigational Site | |
| Brussels, Belgium, 1070 | |
| GSK Investigational Site | |
| Kortrijk, Belgium, 8500 | |
| GSK Investigational Site | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| GSK Investigational Site | |
| Salvador, Bahía, Brazil, 41825-010 | |
| GSK Investigational Site | |
| Rio de Janeiro, Brazil, 20560-120 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| GSK Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Chile | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7591046 | |
| GSK Investigational Site | |
| Santiago, Región Metro De Santiago, Chile, 7500921 | |
| Czech Republic | |
| GSK Investigational Site | |
| Brno, Czech Republic, 656 53 | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 05 | |
| GSK Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| Germany | |
| GSK Investigational Site | |
| Aalen, Baden-Wuerttemberg, Germany, 73428 | |
| GSK Investigational Site | |
| Stuttgart, Baden-Wuerttemberg, Germany, 70190 | |
| GSK Investigational Site | |
| Ulm, Baden-Wuerttemberg, Germany, 89075 | |
| GSK Investigational Site | |
| Coburg, Bayern, Germany, 96450 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80637 | |
| GSK Investigational Site | |
| Fuerstenwalde, Brandenburg, Germany, 15517 | |
| GSK Investigational Site | |
| Ibbenbueren, Nordrhein-Westfalen, Germany, 49477 | |
| GSK Investigational Site | |
| Kiel, Schleswig-Holstein, Germany, 24103 | |
| GSK Investigational Site | |
| Jena, Thueringen, Germany, 07743 | |
| GSK Investigational Site | |
| Berlin, Germany, 10367 | |
| GSK Investigational Site | |
| Berlin, Germany, 10117 | |
| GSK Investigational Site | |
| Hamburg, Germany, 20259 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22457 | |
| GSK Investigational Site | |
| Hamburg, Germany, 22767 | |
| Hungary | |
| GSK Investigational Site | |
| Budapest, Hungary, 1082 | |
| GSK Investigational Site | |
| Szombathely, Hungary, 9700 | |
| GSK Investigational Site | |
| Zalaegerszeg-Pózva, Hungary, 8900 | |
| Italy | |
| GSK Investigational Site | |
| Benevento, Campania, Italy, 82100 | |
| GSK Investigational Site | |
| Napoli, Campania, Italy, 80131 | |
| GSK Investigational Site | |
| Parma, Emilia-Romagna, Italy, 43100 | |
| GSK Investigational Site | |
| Ravenna, Emilia-Romagna, Italy, 48100 | |
| GSK Investigational Site | |
| Rimini, Emilia-Romagna, Italy, 47900 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00152 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00157 | |
| GSK Investigational Site | |
| Pietra Ligure (SV), Liguria, Italy, 17027 | |
| GSK Investigational Site | |
| Bergamo, Lombardia, Italy, 24128 | |
| GSK Investigational Site | |
| Pavia, Lombardia, Italy, 27100 | |
| GSK Investigational Site | |
| Candiolo (TO), Piemonte, Italy, 10060 | |
| GSK Investigational Site | |
| Torino, Piemonte, Italy, 10153 | |
| GSK Investigational Site | |
| Sassari, Sardegna, Italy, 07100 | |
| GSK Investigational Site | |
| Prato, Toscana, Italy, 59100 | |
| GSK Investigational Site | |
| Perugia, Umbria, Italy, 06122 | |
| GSK Investigational Site | |
| Forli, Italy, 47100 | |
| Korea, Republic of | |
| GSK Investigational Site | |
| Gyeonggi-do, Korea, Republic of, 411-769 | |
| GSK Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Latvia | |
| GSK Investigational Site | |
| Daugavpils, Latvia, LV5420 | |
| GSK Investigational Site | |
| Liepaja, Latvia, LV3401 | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1079 | |
| GSK Investigational Site | |
| Riga, Latvia, LV 1002 | |
| Mexico | |
| GSK Investigational Site | |
| Acapulco, Guerrero, Mexico, 39670 | |
| GSK Investigational Site | |
| Guadalajara, Jalisco, Mexico, CP44280 | |
| GSK Investigational Site | |
| Colima, Mexico, 28010 | |
| GSK Investigational Site | |
| Durango, Mexico, 34000 | |
| Netherlands | |
| GSK Investigational Site | |
| Utrecht, Netherlands, 2584 CX | |
| GSK Investigational Site | |
| Utrecht, Netherlands, 3584 CX | |
| New Zealand | |
| GSK Investigational Site | |
| Auckland, New Zealand, 1001 | |
| GSK Investigational Site | |
| Christchurch, New Zealand, 8001 | |
| Pakistan | |
| GSK Investigational Site | |
| Lahore, Pakistan, 54000 | |
| Peru | |
| GSK Investigational Site | |
| Callao, Peru, Callao 2 | |
| GSK Investigational Site | |
| Lima, Peru, Lima 34 | |
| Poland | |
| GSK Investigational Site | |
| Krakow, Poland, 31-826 | |
| GSK Investigational Site | |
| Olsztyn, Poland, 10-228 | |
| GSK Investigational Site | |
| Olsztyn, Poland, 10-226 | |
| GSK Investigational Site | |
| Poznan, Poland, 61-866 | |
| GSK Investigational Site | |
| Warszawa, Poland, 02-781 | |
| GSK Investigational Site | |
| Wroclaw, Poland, 53-413 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 129 128 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 117997 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115 478 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 105005 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 129301 | |
| GSK Investigational Site | |
| Moscow Region, Russian Federation, 143 423 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 197758 | |
| GSK Investigational Site | |
| St. Petersburg, Russian Federation, 197022 | |
| Slovakia | |
| GSK Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 833 10 | |
| GSK Investigational Site | |
| Kosice, Slovakia, 041 91 | |
| South Africa | |
| GSK Investigational Site | |
| Parktown, Gauteng, South Africa, 2193 | |
| GSK Investigational Site | |
| Capital Park, South Africa, 0002 | |
| GSK Investigational Site | |
| Overport, South Africa, 4001 | |
| GSK Investigational Site | |
| Parow, South Africa, 7525 | |
| GSK Investigational Site | |
| Port Elizabeth, South Africa, 6001 | |
| Spain | |
| GSK Investigational Site | |
| Alcorcón/Madrid, Spain, 28922 | |
| GSK Investigational Site | |
| Baracaldo/Vizcaya, Spain, 48903 | |
| GSK Investigational Site | |
| Cuidad Real, Spain, 13002 | |
| GSK Investigational Site | |
| Jaen, Spain, 23007 | |
| GSK Investigational Site | |
| La Laguna (Santa Cruz de Tenerife), Spain, 38320 | |
| GSK Investigational Site | |
| Madrid, Spain, 28035 | |
| GSK Investigational Site | |
| Móstoles/Madrid, Spain, 28935 | |
| GSK Investigational Site | |
| Pontevedra, Spain, 36071 | |
| GSK Investigational Site | |
| San Sebastián, Spain, 20014 | |
| Turkey | |
| GSK Investigational Site | |
| Istanbul, Turkey | |
| GSK Investigational Site | |
| Istanbul, Turkey, 34865 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00075270 History of Changes |
| Obsolete Identifiers: | NCT00085046 |
| Other Study ID Numbers: | EGF30001 |
| Study First Received: | January 7, 2004 |
| Last Updated: | November 21, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
lapatinib ErbB1 kinase inhibitor metastatic breast cancer |
ErbB2 Her2-neu EGFR |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Paclitaxel Lapatinib Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013