Clinical Trial Results:
A Phase IV multicenter, open label study of postmenopausal women with estrogen receptor-positive locally advanced or metastatic breast cancer treated with everolimus (RAD001) in combination with exemestane, with exploratory epigenetic marker analysis (4EVERUK)
Summary
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EudraCT number |
2012-003689-41 |
Trial protocol |
GB |
Global end of trial date |
15 Aug 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Aug 2017
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First version publication date |
30 Aug 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CRAD001YGB11
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01743560 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH-4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 6132411111, Novartis.email@novartis.com
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 6132411111, Novartis.email@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Aug 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Aug 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Aug 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to determine the Overall Response Rate (ORR) at 48 weeks to everolimus (10 mg daily p.o.) and exemestane (25 mg daily p.o.) treatment in postmenopausal women with ER+ BC who have previously experienced recurrence or progression on NSAI therapy.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 49
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
33
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From 65 to 84 years |
16
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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Screening details |
Sixty-seven patients were screened and 52 patients were enrolled. Forty-nine patients had ≥ 1 dose study drug and were considered as Started | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Arm title
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Everolimus and Exemestane | ||||||||||||||||||
Arm description |
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Everolimus
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Investigational medicinal product code |
RAD001
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
5 mg tablets supplied and dosage was 10 mg (2 × 5 mg) p.o. per day
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Investigational medicinal product name |
Exemestane
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
25 mg tablets purchased locally and dosage was 1 tablet 25 mg p.o. per day
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Baseline characteristics reporting groups
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Reporting group title |
Everolimus and Exemestane
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Reporting group description |
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Everolimus and Exemestane
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Reporting group description |
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o. | ||
Subject analysis set title |
Week 12
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at week 12
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Subject analysis set title |
Week 24
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at Week 24
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Subject analysis set title |
Week 36
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at week 36
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Subject analysis set title |
Week 48
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at week 48
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Subject analysis set title |
Day 1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Baseline
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Subject analysis set title |
Week 12
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Week 12 on treatment
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Subject analysis set title |
Week 24
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Week 24 on treatment
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Subject analysis set title |
Week 36
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Week 36 on treatament
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Subject analysis set title |
Week 48
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Week 48 on treatment
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Subject analysis set title |
Week 12
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at week 12
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Subject analysis set title |
Week 24
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at Week 24
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Subject analysis set title |
Week 36
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at week 36
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Subject analysis set title |
Week 48
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Change from baseline at week 48
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End point title |
Best overall response of everolimus and exemestane treatment in postmenopausal women with hormone receptor positive locally advanced or metastatic breast cancer [1] | ||||||||||||||||||||||
End point description |
The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.
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End point type |
Primary
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End point timeframe |
At 48 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical hypothesis testing was done for primary endpoint |
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No statistical analyses for this end point |
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End point title |
Overall response rate of everolimus and exemestane treatment in postmenopausal women with hormone receptor positive locally advanced or metastatic breast cancer [2] | ||||||||
End point description |
The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48. Treatment success is defined as: The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.
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End point type |
Primary
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End point timeframe |
At 48 weeks
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical hypothesis testing was done for primary endpoint |
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No statistical analyses for this end point |
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End point title |
Progression-free Survival (PFS) Events as per Investigators - FAS | ||||||||||||
End point description |
Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review.
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End point type |
Secondary
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End point timeframe |
Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks
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No statistical analyses for this end point |
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End point title |
Progression-free Survival (PFS) by Median Time in weeks as per Investigators - FAS | ||||||||
End point description |
Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review.
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End point type |
Secondary
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End point timeframe |
Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks
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No statistical analyses for this end point |
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End point title |
Progression-free Survival (PFS) - % Event-free probability estimate - FAS | ||||||||||||||||
End point description |
Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review. The PFS was analyzed using the Kaplan Meier method.
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End point type |
Secondary
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End point timeframe |
Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks
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No statistical analyses for this end point |
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End point title |
Overall Survival (OS) Events as per Investigators - FAS | ||||||||||
End point description |
Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact. Time to median OS was not estimable.
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End point type |
Secondary
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End point timeframe |
Start of treatment to the date of death up to approximately 48 weeks
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No statistical analyses for this end point |
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End point title |
Overall Survival (OS) - % Event-free probability estimate - FAS | ||||||||||||||||
End point description |
Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
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End point type |
Secondary
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End point timeframe |
Start of treatment to the date of death up to approximately 48 weeks
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No statistical analyses for this end point |
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End point title |
Quality of life (EORTC Quality of Life Questionnaire of cancer patients QLQ-C30) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The QLQ-C30 is composed of multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status-QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. High scale score=higher response level; a high score for a functional scale=a healthy level of function, high score for the global health status/QoL=high quality of life but a high score for a symptom scale / item=high level of symptomatology/problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations
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End point type |
Secondary
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End point timeframe |
Baseline 12,24,36,48 weeks
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No statistical analyses for this end point |
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End point title |
Percentage of patient responses in EuroQoL 5-dimension questionnaire - FAS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The EQ-5D is a standardized instrument to assess health state values that has been developed, validated and published by the EuroQol Group (EuroQol Group 1990). The EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The EQ-5D descriptive system comprises of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Percentage of participants' responses were presented by visits. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations.
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End point type |
Secondary
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End point timeframe |
Baseline 12,24,36,48 weeks
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No statistical analyses for this end point |
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End point title |
Change from baseline in EuroQoL 5-dimension visual analogue scores - FAS | ||||||||||||||||||||
End point description |
The EQ-5D is another standardized instrument to assess health state values that has been developed, validated and published by the EuroQol Group (EuroQol Group 1990). The EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The EQ-5D descriptive system comprises of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The change in EuroQoL EQ-5D overall health state (VAS), from baseline to each post-baseline time point was described with the mean, and 95% CI of the mean. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations.
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End point type |
Secondary
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End point timeframe |
Baseline 12,24,36,48 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
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Adverse event reporting additional description |
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Everolimus + Exemestane
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Reporting group description |
Everolimus + Exemestane | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Nov 2013 |
Post-trial treatment was to be captured for all patients when they completed the trial, whether they withdrew early or completed the full treatment duration. All new anticancer therapies given after the last dose of the study drug were to be recorded on CRF pages designed to capture antineoplastic therapies. An interim analysis was included on all patients who commenced treatment in the study by 04-Sep-2013. This first interim analysis included all screening and baseline data. A second interim analysis was planned to be performed after all patients completed 24 weeks of treatment (or prematurely discontinued on or before this time). End of study was extended from Week 48 until patients progressed. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |