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.
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,
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There are 125 Locations for this study
Mobile Alabama, 36688, United States
Chandler Arizona, 85224, United States
Fayetteville Arkansas, 72703, United States
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Oxnard California, 93030, United States
Redondo Beach California, 90277, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Greenwood Village Colorado, , United States
Fort Myers Florida, 33901, United States
West Palm Beach Florida, 33401, United States
Indianapolis Indiana, 46227, United States
Overland Park Kansas, 66210, United States
Omaha Nebraska, 68198, United States
Albany New York, 12208, United States
New York New York, 10003, United States
Portland Oregon, 97210, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Dallas Texas, 75251, United States
Tyler Texas, 75702, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23230, United States
Caba Buenos Aires, C1050, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
Posadas Misiones, , Argentina
Rosario Sante Fe, S200K, Argentina
Rio Negro Viedma, 8500, Argentina
Capital Federal , 1417, Argentina
Cordoba , X5004, Argentina
Southport Queensland, 4215, Australia
East Bentleigh Victoria, 3165, Australia
Charleroi , 6000, Belgium
Hasselt , 3500, Belgium
Verviers , 4800, Belgium
Wilrijk , 2610, Belgium
Yvoir , 5530, Belgium
Belo Horizonte MG, 30130, Brazil
Belo Horizonte MG, 30380, Brazil
Rio de Janeiro RJ, 20230, Brazil
Sao Paulo SP, 01246, Brazil
São Paulo SP, 04038, Brazil
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H4J 1, Canada
St-Jerome Quebec, J7Z 5, Canada
Guangzhou Guangdong, 51000, China
Harbin Heilongjiang, 15008, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Shanghai Shanghai, 20003, China
Hangzhou Zhejiang, 31002, China
Beijing , 10002, China
Beijing , 10003, China
Guangzhou , 51006, China
Shanghai , 20002, China
Bogota Cundinamarca, 0000, Colombia
Bogota , , Colombia
Florida Blanca , , Colombia
Monteria , , Colombia
Alexandria , , Egypt
Cairo , , Egypt
Limoges , 87000, France
Rouen , 76000, France
Saint-Herblain Cédex , 44805, France
Strasbourg Cedex , F 670, France
Thonon-les-Bains Cedex , 74203, France
Toulouse Cedex 9 , 31059, France
Villejuif Cedex , 94805, France
Berlin , 10098, Germany
Chemnitz , 09113, Germany
Esslingen , 73730, Germany
Kiel , 24105, Germany
Muenster , 48149, Germany
Athens GR, 151 2, Greece
Thessaloniki GR, 564 0, Greece
Athens , 115 2, Greece
Athens , 18547, Greece
Heraklion Crete , 711 1, Greece
Hong Kong SAR , , Hong Kong
Shatin, New Territories , , Hong Kong
Tuen Mun , , Hong Kong
Wilton Cork, , Ireland
Dublin 4 , , Ireland
Dublin 8 , , Ireland
Dublin 9 , , Ireland
Monza MB, 20900, Italy
Modena MO, 41124, Italy
Camposampiero PD, 35012, Italy
Roma RM, 00128, Italy
Napoli , 80131, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Fukuoka-city Fukuoka, 811-1, Japan
Kitakyushu Fukuoka, 802-0, Japan
Maebashi city Gunma, 371 8, Japan
Sapporo city Hokkaido, 060 8, Japan
Isehara-city Kanagawa, 259-1, Japan
Kumamoto City Kumamoto, 860-8, Japan
Sakyo-ku Kyoto, 606 8, Japan
Osaka-city Osaka, 540-0, Japan
Suita-city Osaka, 565 0, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Chuo-ku Tokyo, 104-8, Japan
Osaka , 537-8, Japan
Gyeonggi-do Korea, 10408, Korea, Republic of
Seoul Korea, 06351, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
Ashrafieh , 16683, Lebanon
Beirut , 1107 , Lebanon
Ciudad De Mexico Distrito Federal, 04980, Mexico
Zaragoza Veracruz, 91910, Mexico
San Borja Lima, 41, Peru
Surquillo Lima, 34, Peru
San Juan , 00921, Puerto Rico
Kazan Tatarstan Republic, 42002, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12912, Russian Federation
Moscow , 14342, Russian Federation
St Petersburg , 19775, Russian Federation
St. Petersburg , 19825, Russian Federation
Bloemfontein , 9301, South Africa
Durban , 4091, South Africa
Pretoria , 0002, South Africa
Genève , 1211, Switzerland
Zuerich , 8038, Switzerland
Taipei Taiwan, ROC, 11217, Taiwan
Kaohsiung , 80756, Taiwan
Taichung , 40447, Taiwan
Taipei , 10002, Taiwan
Taoyuan , 33305, Taiwan
Altunizade , 34662, Turkey
Ankara , 06100, Turkey
Izmir , 35040, Turkey
Izmir , 35340, Turkey
Truro Cornwall, TR1 3, United Kingdom
London , SW3 6, United Kingdom
Sutton , SM2 5, United Kingdom
Valencia Estado Carabobo, 2001, Venezuela
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