Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT01007942
Last Updated: 2017-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
569 participants
INTERVENTIONAL
2009-10-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Everolimus + vinorelbine + trastuzumab
Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
everolimus
Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
vinorelbine
intravenous vinorelbine (25 mg/m2 weekly)
trastuzumab
intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
placebo + vinorelbine + trastuzumab
Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only
Placebo
Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
vinorelbine
intravenous vinorelbine (25 mg/m2 weekly)
trastuzumab
intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Interventions
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everolimus
Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
Placebo
Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
vinorelbine
intravenous vinorelbine (25 mg/m2 weekly)
trastuzumab
intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2+ status defined as IHC 3+ staining or in situ hybridization positive
* Patients with resistance to trastuzumab
* Prior taxane therapy
* Patients with an ECOG performance status of 0 - 2
* Patients with measurable disease as per RECIST criteria
* Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
* Patients must meet laboratory criteria defined in the study within 21 days prior to randomization
Exclusion Criteria
* More than three prior chemotherapy lines for advanced disease.
* Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed \>8 weeks prior to randomization
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
* Peripheral neuropathy ≥ grade 2 at randomization
* Active cardiac disease
* History of cardiac dysfunction
* Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
* Known hypersensitivity to any study medication
* Breastfeeding or pregnant
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Arizona / Cancer Center AZ Onc Assoc
Tucson, Arizona, United States
University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)
Tucson, Arizona, United States
University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer
La Jolla, California, United States
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)
Washington D.C., District of Columbia, United States
Comprehensive Cancer Center - Boca Raton Deerfield Beach
Boca Raton, Florida, United States
Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr
Boca Raton, Florida, United States
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, United States
Memorial Hospital Memorial Cancer Institute
Hollywood, Florida, United States
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)
Orlando, Florida, United States
Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)
Atlanta, Georgia, United States
North Shore University Health System NSU
Evanston, Illinois, United States
Kansas City Cancer Center KCCC- South (2)
Overland Park, Kansas, United States
Maryland Oncology Hematology
Owning Mills, Maryland, United States
Park Nicollet Institute Dept. of Park Nicollet
Saint Louis Park, Minnesota, United States
St. Louis University Cancer Center SLU Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center Unv Nebraska Med Ctr (2)
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
Las Vegas, Nevada, United States
Nevada Cancer Institute Dept. of Nevada Cancer (3)
Las Vegas, Nevada, United States
Overlook Hospital - Carol G Simon Cancer Center Carol G Simon
Summit, New Jersey, United States
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
Lake Success, New York, United States
Duke University Medical Center Dept. of DUMC (2)
Durham, North Carolina, United States
Northwest Cancer Specialists Tutlatin
Portland, Oregon, United States
University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2)
Pittsburgh, Pennsylvania, United States
The Jones Clinic Dept .of The Jones Clinic (3)
Germantown, Tennessee, United States
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6)
Nashville, Tennessee, United States
Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2)
Dallas, Texas, United States
Texas Oncology Presbyterian Hospital (2)
Dallas, Texas, United States
Texas Oncology Texas Onc - Amarillo
Dallas, Texas, United States
Texas Oncology Texas Oncology - Sammons
Dallas, Texas, United States
Texas Oncology Midtown
Dallas, Texas, United States
University of Texas Southwestern Medical Center University of TX SW Med Ctr(2)
Dallas, Texas, United States
University of Texas/MD Anderson Cancer Center SC-5
Houston, Texas, United States
Baylor College of Medicine Baylor
Houston, Texas, United States
Longview Cancer Center Longview Cancer Center (2)
Longview, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States
South Texas Oncology and Hematology, PA South Texas Oncology (2)
San Antonio, Texas, United States
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, United States
Utah Cancer Specialists Utah Cancer (2)
Salt Lake City, Utah, United States
Virginia Cancer Specialists Fairfax No.VA (2)
Fairfax, Virginia, United States
Virginia Oncology Associates Dept. of VOA (2)
Norfolk, Virginia, United States
Swedish Cancer Institute Swedish Cancer Institute
Seattle, Washington, United States
Green Bay Oncology Green Bay Oncology
Green Bay, Wisconsin, United States
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Fatih / Istanbul, , Turkey (Türkiye)
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Truro, Cornwall, United Kingdom
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Countries
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References
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Andre F, O'Regan R, Ozguroglu M, Toi M, Xu B, Jerusalem G, Masuda N, Wilks S, Arena F, Isaacs C, Yap YS, Papai Z, Lang I, Armstrong A, Lerzo G, White M, Shen K, Litton J, Chen D, Zhang Y, Ali S, Taran T, Gianni L. Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 May;15(6):580-91. doi: 10.1016/S1470-2045(14)70138-X. Epub 2014 Apr 14.
Other Identifiers
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2008-008697-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001W2301
Identifier Type: -
Identifier Source: org_study_id
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