Breast Cancer Clinical Trial

Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

Summary

The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult Women (≥ 18 years old).
Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Documentation of negative pregnancy test.
Organ functions at time of inclusion.

Exclusion Criteria:

Prior mTOR inhibitors for the treatment of cancer.
Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
History of central nervous system metastasis.
Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.
Serious peripheral neuropathy.
Cardiac disease or dysfunction.
Uncontrolled hypertension.
HIV.
Pregnant,

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

719

Study ID:

NCT00876395

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 125 Locations for this study

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University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile Alabama, 36688, United States
Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Comprehensive Blood and Cancer Center Dept. of CBCC (2)
Bakersfield California, 93309, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Fullerton California, 92835, United States
University of California at Los Angeles Dept. of UCLA
Los Angeles California, 90095, United States
Ventura County Hematology and Oncology
Oxnard California, 93030, United States
Cancer Care Associates Medical Group Dept. of CCA
Redondo Beach California, 90277, United States
Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc
Santa Barbara California, 93105, United States
Central Coast Medical Oncology Corporation Onc Dept
Santa Maria California, 93454, United States
Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3)
Greenwood Village Colorado, , United States
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)
Fort Myers Florida, 33901, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Central Indiana Cancer Centers CICC - East (3)
Indianapolis Indiana, 46227, United States
Kansas City Cancer Center Dept. of KCCC
Overland Park Kansas, 66210, United States
University of Nebraska Medical Center Unv Nebraska Med Ctr (2)
Omaha Nebraska, 68198, United States
New York Oncology Hematology NYOH Amsterdam
Albany New York, 12208, United States
Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)
New York New York, 10003, United States
Northwest Cancer Specialists Vancouver Cancer Center (3)
Portland Oregon, 97210, United States
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)
Nashville Tennessee, 37203, United States
Texas Oncology Charles A. Sammons Cancer Ctr
Dallas Texas, 75246, United States
Texas Oncology P A SC-Austin
Dallas Texas, 75251, United States
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler Texas, 75702, United States
Virginia Oncology Associates SC
Norfolk Virginia, 23502, United States
Virginia Cancer Institute VCI (3)
Richmond Virginia, 23230, United States
Novartis Investigative Site
Caba Buenos Aires, C1050, Argentina
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Mar del Plata Buenos Aires, B7600, Argentina
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Posadas Misiones, , Argentina
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Rosario Sante Fe, S200K, Argentina
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Rio Negro Viedma, 8500, Argentina
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Capital Federal , 1417, Argentina
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Cordoba , X5004, Argentina
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Southport Queensland, 4215, Australia
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East Bentleigh Victoria, 3165, Australia
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Charleroi , 6000, Belgium
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Hasselt , 3500, Belgium
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Verviers , 4800, Belgium
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Wilrijk , 2610, Belgium
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Yvoir , 5530, Belgium
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Belo Horizonte MG, 30130, Brazil
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Belo Horizonte MG, 30380, Brazil
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Rio de Janeiro RJ, 20230, Brazil
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Sao Paulo SP, 01246, Brazil
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São Paulo SP, 04038, Brazil
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Montreal Quebec, H2W 1, Canada
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Montreal Quebec, H4J 1, Canada
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St-Jerome Quebec, J7Z 5, Canada
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Guangzhou Guangdong, 51000, China
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Harbin Heilongjiang, 15008, China
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Nanjing Jiangsu, 21000, China
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Nanjing Jiangsu, 21000, China
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Shanghai Shanghai, 20003, China
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Hangzhou Zhejiang, 31002, China
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Beijing , 10002, China
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Beijing , 10003, China
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Guangzhou , 51006, China
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Shanghai , 20002, China
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Bogota Cundinamarca, 0000, Colombia
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Bogota , , Colombia
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Florida Blanca , , Colombia
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Monteria , , Colombia
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Alexandria , , Egypt
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Cairo , , Egypt
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Limoges , 87000, France
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Rouen , 76000, France
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Saint-Herblain Cédex , 44805, France
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Strasbourg Cedex , F 670, France
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Thonon-les-Bains Cedex , 74203, France
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Toulouse Cedex 9 , 31059, France
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Villejuif Cedex , 94805, France
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Berlin , 10098, Germany
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Chemnitz , 09113, Germany
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Esslingen , 73730, Germany
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Kiel , 24105, Germany
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Muenster , 48149, Germany
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Athens GR, 151 2, Greece
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Thessaloniki GR, 564 0, Greece
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Athens , 115 2, Greece
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Athens , 18547, Greece
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Heraklion Crete , 711 1, Greece
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Hong Kong SAR , , Hong Kong
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Shatin, New Territories , , Hong Kong
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Tuen Mun , , Hong Kong
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Wilton Cork, , 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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Monza MB, 20900, Italy
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Modena MO, 41124, Italy
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Camposampiero PD, 35012, Italy
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Roma RM, 00128, Italy
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Napoli , 80131, Italy
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Nagoya Aichi, 464-8, Japan
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Kashiwa Chiba, 277-8, Japan
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Fukuoka-city Fukuoka, 811-1, Japan
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Kitakyushu Fukuoka, 802-0, Japan
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Maebashi city Gunma, 371 8, Japan
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Sapporo city Hokkaido, 060 8, Japan
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Isehara-city Kanagawa, 259-1, Japan
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Kumamoto City Kumamoto, 860-8, Japan
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Sakyo-ku Kyoto, 606 8, Japan
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Osaka-city Osaka, 540-0, Japan
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Suita-city Osaka, 565 0, Japan
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Kitaadachi-gun Saitama, 362-0, Japan
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Bunkyo-ku Tokyo, 113-8, Japan
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Chuo-ku Tokyo, 104-8, Japan
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Osaka , 537-8, Japan
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Gyeonggi-do Korea, 10408, Korea, Republic of
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Seoul Korea, 06351, Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Ashrafieh , 16683, Lebanon
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Beirut , 1107 , Lebanon
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Ciudad De Mexico Distrito Federal, 04980, Mexico
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Zaragoza Veracruz, 91910, Mexico
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San Borja Lima, 41, Peru
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Surquillo Lima, 34, Peru
San Juan VA Hospital San Juan Hospital
San Juan , 00921, Puerto Rico
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Kazan Tatarstan Republic, 42002, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 12912, Russian Federation
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Moscow , 14342, Russian Federation
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St Petersburg , 19775, Russian Federation
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St. Petersburg , 19825, Russian Federation
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Bloemfontein , 9301, South Africa
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Durban , 4091, South Africa
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Pretoria , 0002, South Africa
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Genève , 1211, Switzerland
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Zuerich , 8038, Switzerland
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Taipei Taiwan, ROC, 11217, Taiwan
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Kaohsiung , 80756, Taiwan
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Taichung , 40447, Taiwan
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Taipei , 10002, Taiwan
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Taoyuan , 33305, Taiwan
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Altunizade , 34662, Turkey
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Ankara , 06100, Turkey
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Izmir , 35040, Turkey
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Izmir , 35340, Turkey
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Truro Cornwall, TR1 3, United Kingdom
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London , SW3 6, United Kingdom
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Sutton , SM2 5, United Kingdom
Novartis Investigative Site
Valencia Estado Carabobo, 2001, Venezuela

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

719

Study ID:

NCT00876395

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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