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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00876395
Registration number
NCT00876395
Ethics application status
Date submitted
2/04/2009
Date registered
6/04/2009
Date last updated
19/12/2018
Titles & IDs
Public title
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
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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
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Secondary ID [1]
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0
2008-006556-21
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Secondary ID [2]
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0
CRAD001J2301
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Universal Trial Number (UTN)
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Trial acronym
BOLERO-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Primary outcome [2]
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Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population
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Assessment method [2]
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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.
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Timepoint [2]
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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
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Secondary outcome [1]
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Overall Survival (OS) - Full Population
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Assessment method [1]
0
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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.
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Timepoint [1]
0
0
up to about 76 months
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Secondary outcome [2]
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Overall Survival (OS) - HR-negative Population
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Assessment method [2]
0
0
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.
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Timepoint [2]
0
0
up to about 76 months
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Secondary outcome [3]
0
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Overall Response Rate (ORR) - Full Population
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Assessment method [3]
0
0
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.
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Timepoint [3]
0
0
up to about 23 months
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Secondary outcome [4]
0
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Overall Response Rate (ORR) - HR-negative Population
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Assessment method [4]
0
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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.
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Timepoint [4]
0
0
up to about 23 months
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Secondary outcome [5]
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Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population
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Assessment method [5]
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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.
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Timepoint [5]
0
0
up to about 23 months
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Secondary outcome [6]
0
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Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population
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Assessment method [6]
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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.
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Timepoint [6]
0
0
up to about 23 months
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Secondary outcome [7]
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Time to Overall Response Based on Investigator - Full Population
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Assessment method [7]
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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.
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Timepoint [7]
0
0
up to about 23 months
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Secondary outcome [8]
0
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Time to Overall Response Based on Investigator - HR-negative Population
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Assessment method [8]
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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.
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Timepoint [8]
0
0
up to about 23 months
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Secondary outcome [9]
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Overall Response (OR) - Full Population
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Assessment method [9]
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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.
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Timepoint [9]
0
0
up to about 23 months
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Secondary outcome [10]
0
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Overall Response (OR) - HR-negative Population
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Assessment method [10]
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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.
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Timepoint [10]
0
0
up to about 23 months
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Secondary outcome [11]
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Everolimus Blood Level Concentrations at Steady States for Everolimus
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Assessment method [11]
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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
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Timepoint [11]
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predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22
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Secondary outcome [12]
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Paclitaxel Plasma Concentrations
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Assessment method [12]
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Blood levels at steady states for everolimus/placebo
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Timepoint [12]
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Cycle 2/Day 15 (Pre-infusion and end of infusion)
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Secondary outcome [13]
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Trastuzumab Serum Concentrations
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Assessment method [13]
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Blood levels at steady states for everolimus/placebo
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Timepoint [13]
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Cycle 4/Day 1 (Pre-infusion and end of infusion)
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Secondary outcome [14]
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Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population
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Assessment method [14]
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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.
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Timepoint [14]
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up to about 56 months
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Secondary outcome [15]
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Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population
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Assessment method [15]
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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.
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Timepoint [15]
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up to about 56 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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,
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/10/2017
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Sample size
Target
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Accrual to date
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Final
719
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Southport
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Recruitment hospital [2]
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Novartis Investigative Site - East Bentleigh
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Recruitment postcode(s) [1]
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4215 - Southport
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Recruitment postcode(s) [2]
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3165 - East Bentleigh
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Indiana
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Kansas
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Nebraska
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New York
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Oregon
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Tennessee
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Misiones
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Argentina
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Sante Fe
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Argentina
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Viedma
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Argentina
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Capital Federal
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Argentina
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Cordoba
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Charleroi
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Guangzhou
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Cairo
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Limoges
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Rouen
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MB
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Italy
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MO
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Italy
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PD
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Italy
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RM
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Kyoto
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Osaka
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Tokyo
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Korea, Republic of
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Korea
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Seoul
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Lebanon
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Russian Federation
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Tatarstan Republic
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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South Africa
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Bloemfontein
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South Africa
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Durban
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South Africa
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Pretoria
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Switzerland
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Genève
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Switzerland
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Zuerich
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Taiwan
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Taiwan, ROC
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Altunizade
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Turkey
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Ankara
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Turkey
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Izmir
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United Kingdom
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Cornwall
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United Kingdom
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London
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United Kingdom
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Sutton
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Venezuela
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Estado Carabobo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00876395
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00876395
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