Clinical Trial Results:
A multicenter phase II study to determine the efficacy of capecitabine as first line monochemotherapy in patients with HER2 negative, medium-risk, metastatic breast cancer
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Summary
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EudraCT number |
2005-000074-51 |
Trial protocol |
DE |
Global end of trial date |
25 Jun 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Dec 2021
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First version publication date |
23 Dec 2021
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Other versions |
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Summary report(s) |
MoniCa CSR Synopsis |
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 |
GBG 39
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00196820 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GBG Forschungs GmbH
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Sponsor organisation address |
Martin Behaim Str. 12, Neu-Isenburg, Germany,
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Public contact |
Medicine and Research, GBG Forschungs GmbH, +49 610274800, publications@gbg.de
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Scientific contact |
Medicine and Research, GBG Forschungs GmbH, +49 610274800, publications@gbg.de
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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 |
14 Aug 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Jun 2009
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To determine the time to disease progression in patients with HER2 negative metastatic breast cancer after 1st line monochemotherapy with capecitabine
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Protection of trial subjects |
The trial protocol including amendments, the patient information and the informed consent were reviewed and approved from a properly constituted IRB/IEC for each site prior to the study start. The trial was in compliance with the International Conference on Harmonization (ICH) - Harmonized Tripartite Guideline for Good Clinical Practice (GCP) (E6), and the Commission Directives in the European Community as well as with the applicable German national laws and regulations, and with Declaration of Helsinki and its revisions in all aspects of preparation, monitoring, reporting, auditing, and archiving.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jul 2005
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
10 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Germany: 165
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Worldwide total number of subjects |
165
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EEA total number of subjects |
165
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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) |
81
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From 65 to 84 years |
80
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85 years and over |
4
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Recruitment
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Recruitment details |
Approximately 2.5 years (Q-III 2005 –Q-I 2008) in 35 sites in Germany. 200 patients were planned. The study was stopped after 165 patients were enrolled because of a change of standard of care for 1st line metastatic breast cancer. Eventually, 161 patients were treated and included for efficacy and safety analyses. | ||||||||||||||||
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Pre-assignment
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Screening details |
Female/male >18yrs with histologically confirmed BC, locally advanced or metastatic BC not suitable for surgery or RT alone, HER2-, and measurable/nonmeasurable target lesions acc. to WHO; previously treated with adjuvant CT (without capecitabine) or adjuvant/palliative ET, bisphosphonates or immunotherapies; >=4wks since RT with full recovery | ||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
165 | ||||||||||||||||
Number of subjects completed |
161 | ||||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 2 | ||||||||||||||||
Reason: Number of subjects |
Disease progression: 1 | ||||||||||||||||
Reason: Number of subjects |
patient wish: 1 | ||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Capecitabine | ||||||||||||||||
Arm description |
Capecitabine 2000 mg/m² orally on days 1-14 q day 22. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Capecitabine
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Investigational medicinal product code |
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Other name |
Xeloda®
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2000 mg/m² orally on days 1-14 q day 22
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 165 patients were enrolled, but 4 did not start Treatment. 161 started Treatment and are reported in the baseline period |
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Capecitabine
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Reporting group description |
Capecitabine 2000 mg/m² orally on days 1-14 q day 22. | ||
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End point title |
time to disease progression (TTP) [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
TTP is defined as time (in weeks) from the registration until disease progression (or death due to any cause). Pts who had not experienced progression until analysis were censored at the date of last tumor assessment, last FU date or last date drug log.
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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 analyses for this end point. The median TTP was 7.9 months (31.6 weeks; 95% confidence interval (CI) 26.9–36.3), which was significantly longer than the hypothesis of a minimum of 25 weeks (p < 0.05). |
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| Notes [2] - At database lock 130 disease progressions and 72 deaths (3 without preceding progression) events |
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall survival | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Overall survival is the time (in weeks) from the registration until death due to any cause; patients lost to follow-up was censored at the date of the last contact.
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| Notes [3] - 72 Events/89 censored |
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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 |
All adverse events occurring during the study treatment period were reported
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Adverse event reporting additional description |
Only drug-related SAEs are reported;
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
n.a. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Capecitabine
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Reporting group description |
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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? No | |||
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. | |||
| 200 patients were planned. The study was stopped after 165 patients were enrolled because of a change of standard of care for 1st line metastatic breast cancer. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/20797843 |
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