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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/NCT01007942
Registration number
NCT01007942
Ethics application status
Date submitted
2/11/2009
Date registered
4/11/2009
Date last updated
5/04/2017
Titles & IDs
Public title
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
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Scientific title
A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer.
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Secondary ID [1]
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2008-008697-31
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Secondary ID [2]
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CRAD001W2301
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Universal Trial Number (UTN)
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Trial acronym
BOLERO-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2/Neu Over-expressing Locally Advanced Breast Cancer
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Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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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 - vinorelbine
Treatment: Drugs - trastuzumab
Experimental: 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)
Placebo Comparator: 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
Treatment: Drugs: everolimus
Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
Treatment: Drugs: Placebo
Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
Treatment: Drugs: vinorelbine
intravenous vinorelbine (25 mg/m2 weekly)
Treatment: Drugs: trastuzumab
intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
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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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Progressive-free Survival (PFS) Per Investigator Assessment
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Assessment method [1]
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PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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Timepoint [1]
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Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.
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Timepoint [1]
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Every 3 months until death up to 41 months
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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Timepoint [2]
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Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
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Secondary outcome [3]
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Clinical Benefit Rate (CBR)
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Assessment method [3]
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CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.
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Timepoint [3]
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Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
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Secondary outcome [4]
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Median Time to Deterioration of the ECOG Performance Status Score
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Assessment method [4]
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Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, & physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead
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Timepoint [4]
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baseline, until disease progression or death up to about 41 months
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Secondary outcome [5]
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PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
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Assessment method [5]
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PRO = patient reported outcomes; Time to deterioration (= 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, & social functioning [EF, PF, & SF]). It contains 30 items & is composed of multi-item scales & single-item measures. These include 5 functional scales (physical, role, emotional, social & cognitive functioning), 3 symptom scales (fatigue, pain, nausea, & vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia & financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest & disclosed here.
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Timepoint [5]
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Baseline, until disease progression or death up to about 41 months
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Secondary outcome [6]
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Everolimus Blood Concentrations by Leading Dose and Time Point
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Assessment method [6]
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Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.
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Timepoint [6]
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Cycle 2, Day 1
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Secondary outcome [7]
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Vinorelbine Blood Concentrations by Leading Dose and Time Point
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Assessment method [7]
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Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.
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Timepoint [7]
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Cycle 2, Day 1
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Secondary outcome [8]
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Trastuzumab Blood Concentrations by Leading Dose and Time Point
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Assessment method [8]
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Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.
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Timepoint [8]
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Cycle 3, Day 1
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Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed invasive breast carcinoma with locally
recurrent or radiological evidence of metastatic disease. Locally recurrent disease
must not be amenable to resection with curative intent.
- 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
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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 or vinca alkaloid agents for the treatment of cancer
- 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
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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 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
1/10/2009
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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
1/06/2015
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Sample size
Target
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Accrual to date
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Final
569
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Kogarah
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Novartis Investigative Site - St. Leonards
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Novartis Investigative Site - South Brisbane
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Novartis Investigative Site - Southport
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Novartis Investigative Site - Hobart
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Recruitment hospital [6]
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Novartis Investigative Site - East Bentleigh
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2065 - St. Leonards
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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7000 - Hobart
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Recruitment postcode(s) [6]
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3165 - East Bentleigh
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Recruitment outside Australia
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CT
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Lublin
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Kosice
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Andalucia
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Barcelona
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Country [97]
0
0
Spain
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State/province [97]
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0
Catalunya
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Country [98]
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0
Spain
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State/province [98]
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0
Comunidad Valenciana
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Country [99]
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0
Spain
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State/province [99]
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Galicia
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Country [100]
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Spain
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State/province [100]
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Madrid
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Country [101]
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Spain
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State/province [101]
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Santa Cruz de Tenerife
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Country [102]
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Spain
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State/province [102]
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0
Zaragoza
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Country [103]
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0
Thailand
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State/province [103]
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0
Bangkok
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Country [104]
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0
Thailand
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State/province [104]
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0
Songkla
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Country [105]
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0
Turkey
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State/province [105]
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0
Ankara
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Country [106]
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Turkey
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State/province [106]
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0
Fatih / Istanbul
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Country [107]
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Turkey
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State/province [107]
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Izmir
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Country [108]
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United Kingdom
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State/province [108]
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Cornwall
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Country [109]
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0
United Kingdom
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State/province [109]
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0
England
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Country [110]
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0
United Kingdom
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State/province [110]
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0
Bournemouth
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Country [111]
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0
United Kingdom
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State/province [111]
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0
Leeds
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Country [112]
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0
United Kingdom
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State/province [112]
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London
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Country [113]
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United Kingdom
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State/province [113]
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0
Manchester
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Country [114]
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0
United Kingdom
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State/province [114]
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0
Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase III, double-blind, placebo-controlled multinational study will assess the
combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine
and trastuzumab with respect to progressive-free survival and over survival in HER2/neu
positive women with locally advanced or metastatic breast cancer who are resistant to
trastuzumab and have been pre-treated with a taxane.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01007942
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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0
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Phone
0
0
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01007942
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