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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/NCT01783444
Registration number
NCT01783444
Ethics application status
Date submitted
11/01/2013
Date registered
5/02/2013
Date last updated
26/02/2021
Titles & IDs
Public title
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
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Scientific title
A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.
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Secondary ID [1]
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2012-003757-28
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Secondary ID [2]
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CRAD001Y2201
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Universal Trial Number (UTN)
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Trial acronym
BOLERO-6
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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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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 - Capecitabine
Treatment: Drugs - Exemestane
Treatment: Drugs - Everolimus
Experimental: Capecitabine 1250 mg/m2 - Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Experimental: Everolimus 10 mg - Everolimus (10 mg daily) (investigational arm).
Active Comparator: Everolimus 10 mg + Exemestane 25 mg - Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).
Treatment: Drugs: Capecitabine
Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied)
Treatment: Drugs: Exemestane
Exemestane, tablets for oral use, 25 mg per day in (locally supplied)
Treatment: Drugs: Everolimus
Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied)
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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) - Everolimus Plus Exemestane Versus Everolimus Alone
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Assessment method [1]
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Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.
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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 39 months
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Secondary outcome [1]
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Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone
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Assessment method [1]
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Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.
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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 39 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive.
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Timepoint [2]
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Every 3 months following end of treatment visit, assessed for approximately 54 months
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Secondary outcome [3]
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Overall Response Rate (ORR)
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Assessment method [3]
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Overall Response Rate (ORR) as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1 This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at baseline are absent at subsequent visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: 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. Only descriptive statistics.
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Timepoint [3]
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From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months
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Secondary outcome [4]
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Clinical Benefit Rate (CBR)
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Assessment method [4]
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Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: 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, Stable disease (SD), neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; CBR = CR+PR+SD. Only descriptive statistics.
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Timepoint [4]
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From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months
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Secondary outcome [5]
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Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration
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Assessment method [5]
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The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess physical health of subjects,ranging from 0 (most active) to 5 (least active). Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.
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Timepoint [5]
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Baseline, every 6 weeks up to about 43 months
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Secondary outcome [6]
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Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life
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Assessment method [6]
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The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive 10% (5-point) deterioration is defined as a decrease in score by at least 10% (5-points) compared to baseline, with no later increase above this threshold observed during the course of the study.
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Timepoint [6]
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Baseline, every 6 weeks up to about 43 months
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Secondary outcome [7]
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Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12
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Assessment method [7]
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TSQM was used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The differences in mean scale scores between weeks 3 and 12 comparing treatment satisfaction in the different treatment arms: everolimus + exemestane combination therapy versus everolimus monotherapy, and everolimus + exemestane combination therapy versus capecitabine monotherapy. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain.
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Timepoint [7]
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Week 3, Week 12
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Eligibility
Key inclusion criteria
Key
- Women with locally advanced, recurrent, or metastatic breast cancer along with
confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least
one lesion = 10 mm by CT or MRI that can be accurately measured in at least one dimension
(CT scan slice thickness = 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the
absence of measurable disease as defined above.
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Minimum age
18
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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
- Patients who received more than one chemotherapy line. Patients with only non-measurable
lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment
with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
26/02/2013
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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
30/07/2018
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Sample size
Target
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Accrual to date
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Final
309
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Randwick
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Recruitment hospital [2]
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Novartis Investigative Site - Wahroonga
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Novartis Investigative Site - Malvern
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Novartis Investigative Site - Parkville
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2031 - Randwick
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2076 - Wahroonga
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3144 - Malvern
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment outside Australia
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
This was a three-arm, randomized, open label, multi-center phase II study investigating the
combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg
daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with
estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or
progression on letrozole or anastrozole.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01783444
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Trial related presentations / publications
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01783444
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