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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00876395




Registration number
NCT00876395
Ethics application status
Date submitted
2/04/2009
Date registered
3/04/2009
Date last updated
18/12/2018

Titles & IDs
Public title
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
Scientific title
A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
2008-006556-21
Secondary ID [2] 0 0
CRAD001J2301
Universal Trial Number (UTN)
Trial acronym
BOLERO-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Everolimus
Treatment: Drugs - Placebo
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Everolimus
Treatment: Drugs - Placebo
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Paclitaxel

Experimental: Everolimus + Paclitaxel + Trastuzumab - Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22

Placebo Comparator: Placebo + Paclitaxel + Trastuzumab - Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22

Experimental: Everolimus + Paclitaxel + Trastuzumab - Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22

Placebo Comparator: Placebo + Paclitaxel + Trastuzumab - Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22


Treatment: Drugs: Everolimus
Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

Treatment: Drugs: Placebo
Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

Treatment: Drugs: Trastuzumab
Trastuzumab, 2 mg/kg weekly was used intravenously.

Treatment: Drugs: Paclitaxel
Paclitaxel, 80 mg/m2 weekly was used intravenously.

Treatment: Drugs: Everolimus
Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

Treatment: Drugs: Placebo
Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

Treatment: Drugs: Trastuzumab
Trastuzumab, 2 mg/kg weekly was used intravenously.

Treatment: Drugs: Paclitaxel
Paclitaxel, 80 mg/m2 weekly was used intravenously.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population - PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.
Timepoint [1] 0 0
date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months
Primary outcome [2] 0 0
Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population - PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population.
Timepoint [2] 0 0
date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months
Primary outcome [3] 0 0
Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population - PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.
Timepoint [3] 0 0
date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months
Primary outcome [4] 0 0
Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population - PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population.
Timepoint [4] 0 0
date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 56 months
Secondary outcome [1] 0 0
Overall Survival (OS) - Full Population - OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population.
Timepoint [1] 0 0
up to about 76 months
Secondary outcome [2] 0 0
Overall Survival (OS) - HR-negative Population - OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population.
Timepoint [2] 0 0
up to about 76 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR) - Full Population - ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [3] 0 0
up to about 23 months
Secondary outcome [4] 0 0
Overall Response Rate (ORR) - HR-negative Population - ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [4] 0 0
up to about 23 months
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population - CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [5] 0 0
up to about 23 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population - CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [6] 0 0
up to about 23 months
Secondary outcome [7] 0 0
Time to Overall Response Based on Investigator - Full Population - Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [7] 0 0
up to about 23 months
Secondary outcome [8] 0 0
Time to Overall Response Based on Investigator - HR-negative Population - Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [8] 0 0
up to about 23 months
Secondary outcome [9] 0 0
Overall Response (OR) - Full Population - OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [9] 0 0
up to about 23 months
Secondary outcome [10] 0 0
Overall Response (OR) - HR-negative Population - OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [10] 0 0
up to about 23 months
Secondary outcome [11] 0 0
Everolimus Blood Level Concentrations at Steady States for Everolimus - Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days
Timepoint [11] 0 0
predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22
Secondary outcome [12] 0 0
Paclitaxel Plasma Concentrations - Blood levels at steady states for everolimus/placebo
Timepoint [12] 0 0
Cycle 2/Day 15 (Pre-infusion and end of infusion)
Secondary outcome [13] 0 0
Trastuzumab Serum Concentrations - Blood levels at steady states for everolimus/placebo
Timepoint [13] 0 0
Cycle 4/Day 1 (Pre-infusion and end of infusion)
Secondary outcome [14] 0 0
Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population - Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.
Timepoint [14] 0 0
up to about 56 months
Secondary outcome [15] 0 0
Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population - Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.
Timepoint [15] 0 0
up to about 56 months
Secondary outcome [16] 0 0
Overall Survival (OS) - Full Population - OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population.
Timepoint [16] 0 0
up to about 76 months
Secondary outcome [17] 0 0
Overall Survival (OS) - HR-negative Population - OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population.
Timepoint [17] 0 0
up to about 76 months
Secondary outcome [18] 0 0
Overall Response Rate (ORR) - Full Population - ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [18] 0 0
up to about 23 months
Secondary outcome [19] 0 0
Overall Response Rate (ORR) - HR-negative Population - ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [19] 0 0
up to about 23 months
Secondary outcome [20] 0 0
Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population - CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [20] 0 0
up to about 23 months
Secondary outcome [21] 0 0
Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population - CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [21] 0 0
up to about 23 months
Secondary outcome [22] 0 0
Time to Overall Response Based on Investigator - Full Population - Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [22] 0 0
up to about 23 months
Secondary outcome [23] 0 0
Time to Overall Response Based on Investigator - HR-negative Population - Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [23] 0 0
up to about 23 months
Secondary outcome [24] 0 0
Overall Response (OR) - Full Population - OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [24] 0 0
up to about 23 months
Secondary outcome [25] 0 0
Overall Response (OR) - HR-negative Population - OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.
Timepoint [25] 0 0
up to about 23 months
Secondary outcome [26] 0 0
Everolimus Blood Level Concentrations at Steady States for Everolimus - Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days
Timepoint [26] 0 0
predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22
Secondary outcome [27] 0 0
Paclitaxel Plasma Concentrations - Blood levels at steady states for everolimus/placebo
Timepoint [27] 0 0
Cycle 2/Day 15 (Pre-infusion and end of infusion)
Secondary outcome [28] 0 0
Trastuzumab Serum Concentrations - Blood levels at steady states for everolimus/placebo
Timepoint [28] 0 0
Cycle 4/Day 1 (Pre-infusion and end of infusion)
Secondary outcome [29] 0 0
Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population - Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.
Timepoint [29] 0 0
up to about 56 months
Secondary outcome [30] 0 0
Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population - Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.
Timepoint [30] 0 0
up to about 56 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [2] 0 0
Novartis Investigative Site - East Bentleigh
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Misiones
Country [17] 0 0
Argentina
State/province [17] 0 0
Sante Fe
Country [18] 0 0
Argentina
State/province [18] 0 0
Viedma
Country [19] 0 0
Argentina
State/province [19] 0 0
Capital Federal
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Belgium
State/province [21] 0 0
Charleroi
Country [22] 0 0
Belgium
State/province [22] 0 0
Hasselt
Country [23] 0 0
Belgium
State/province [23] 0 0
Verviers
Country [24] 0 0
Belgium
State/province [24] 0 0
Wilrijk
Country [25] 0 0
Belgium
State/province [25] 0 0
Yvoir
Country [26] 0 0
Brazil
State/province [26] 0 0
MG
Country [27] 0 0
Brazil
State/province [27] 0 0
RJ
Country [28] 0 0
Brazil
State/province [28] 0 0
SP
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
China
State/province [30] 0 0
Guangdong
Country [31] 0 0
China
State/province [31] 0 0
Heilongjiang
Country [32] 0 0
China
State/province [32] 0 0
Jiangsu
Country [33] 0 0
China
State/province [33] 0 0
Shanghai
Country [34] 0 0
China
State/province [34] 0 0
Zhejiang
Country [35] 0 0
China
State/province [35] 0 0
Beijing
Country [36] 0 0
China
State/province [36] 0 0
Guangzhou
Country [37] 0 0
Colombia
State/province [37] 0 0
Cundinamarca
Country [38] 0 0
Colombia
State/province [38] 0 0
Bogota
Country [39] 0 0
Colombia
State/province [39] 0 0
Florida Blanca
Country [40] 0 0
Colombia
State/province [40] 0 0
Monteria
Country [41] 0 0
Egypt
State/province [41] 0 0
Alexandria
Country [42] 0 0
Egypt
State/province [42] 0 0
Cairo
Country [43] 0 0
France
State/province [43] 0 0
Limoges
Country [44] 0 0
France
State/province [44] 0 0
Rouen
Country [45] 0 0
France
State/province [45] 0 0
Saint-Herblain Cédex
Country [46] 0 0
France
State/province [46] 0 0
Strasbourg Cedex
Country [47] 0 0
France
State/province [47] 0 0
Thonon-les-Bains Cedex
Country [48] 0 0
France
State/province [48] 0 0
Toulouse Cedex 9
Country [49] 0 0
France
State/province [49] 0 0
Villejuif Cedex
Country [50] 0 0
Germany
State/province [50] 0 0
Berlin
Country [51] 0 0
Germany
State/province [51] 0 0
Chemnitz
Country [52] 0 0
Germany
State/province [52] 0 0
Esslingen
Country [53] 0 0
Germany
State/province [53] 0 0
Kiel
Country [54] 0 0
Germany
State/province [54] 0 0
Muenster
Country [55] 0 0
Greece
State/province [55] 0 0
GR
Country [56] 0 0
Greece
State/province [56] 0 0
Athens
Country [57] 0 0
Greece
State/province [57] 0 0
Heraklion Crete
Country [58] 0 0
Hong Kong
State/province [58] 0 0
Hong Kong SAR
Country [59] 0 0
Hong Kong
State/province [59] 0 0
Shatin, New Territories
Country [60] 0 0
Hong Kong
State/province [60] 0 0
Tuen Mun
Country [61] 0 0
Ireland
State/province [61] 0 0
Cork
Country [62] 0 0
Ireland
State/province [62] 0 0
Dublin 4
Country [63] 0 0
Ireland
State/province [63] 0 0
Dublin 8
Country [64] 0 0
Ireland
State/province [64] 0 0
Dublin 9
Country [65] 0 0
Italy
State/province [65] 0 0
MB
Country [66] 0 0
Italy
State/province [66] 0 0
MO
Country [67] 0 0
Italy
State/province [67] 0 0
PD
Country [68] 0 0
Italy
State/province [68] 0 0
RM
Country [69] 0 0
Italy
State/province [69] 0 0
Napoli
Country [70] 0 0
Japan
State/province [70] 0 0
Aichi
Country [71] 0 0
Japan
State/province [71] 0 0
Chiba
Country [72] 0 0
Japan
State/province [72] 0 0
Fukuoka
Country [73] 0 0
Japan
State/province [73] 0 0
Gunma
Country [74] 0 0
Japan
State/province [74] 0 0
Hokkaido
Country [75] 0 0
Japan
State/province [75] 0 0
Kanagawa
Country [76] 0 0
Japan
State/province [76] 0 0
Kumamoto
Country [77] 0 0
Japan
State/province [77] 0 0
Kyoto
Country [78] 0 0
Japan
State/province [78] 0 0
Osaka
Country [79] 0 0
Japan
State/province [79] 0 0
Saitama
Country [80] 0 0
Japan
State/province [80] 0 0
Tokyo
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Korea
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Seoul
Country [83] 0 0
Lebanon
State/province [83] 0 0
Ashrafieh
Country [84] 0 0
Lebanon
State/province [84] 0 0
Beirut
Country [85] 0 0
Mexico
State/province [85] 0 0
Distrito Federal
Country [86] 0 0
Mexico
State/province [86] 0 0
Veracruz
Country [87] 0 0
Peru
State/province [87] 0 0
Lima
Country [88] 0 0
Puerto Rico
State/province [88] 0 0
San Juan
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Tatarstan Republic
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moscow
Country [91] 0 0
Russian Federation
State/province [91] 0 0
St Petersburg
Country [92] 0 0
Russian Federation
State/province [92] 0 0
St. Petersburg
Country [93] 0 0
South Africa
State/province [93] 0 0
Bloemfontein
Country [94] 0 0
South Africa
State/province [94] 0 0
Durban
Country [95] 0 0
South Africa
State/province [95] 0 0
Pretoria
Country [96] 0 0
Switzerland
State/province [96] 0 0
Genève
Country [97] 0 0
Switzerland
State/province [97] 0 0
Zuerich
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taiwan, ROC
Country [99] 0 0
Taiwan
State/province [99] 0 0
Kaohsiung
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taichung
Country [101] 0 0
Taiwan
State/province [101] 0 0
Taipei
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taoyuan
Country [103] 0 0
Turkey
State/province [103] 0 0
Altunizade
Country [104] 0 0
Turkey
State/province [104] 0 0
Ankara
Country [105] 0 0
Turkey
State/province [105] 0 0
Izmir
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Cornwall
Country [107] 0 0
United Kingdom
State/province [107] 0 0
London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Sutton
Country [109] 0 0
Venezuela
State/province [109] 0 0
Estado Carabobo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00876395
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications