Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer
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ClinicalTrials.gov Identifier: NCT01095003 |
Recruitment Status :
Completed
First Posted : March 29, 2010
Results First Posted : September 13, 2019
Last Update Posted : April 28, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | March 24, 2010 | |||
First Posted Date ICMJE | March 29, 2010 | |||
Results First Submitted Date ICMJE | May 27, 2019 | |||
Results First Posted Date ICMJE | September 13, 2019 | |||
Last Update Posted Date | April 28, 2022 | |||
Study Start Date ICMJE | May 2009 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival [ Time Frame: Baseline up to 2 years 7 months ] PFS is defined as time from date of randomization to date of the first documentation of objective tumor progression (according to the Independent Response Review Committee (IRC) and based on RECIST version 1.1) or death due to any cause.
The PFS was primarily analysed in the Intent-to-treat (ITT) population. Patients lost to follow-up, or without a known record of progression or death at time of analysis had the progression-free survival censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression, whichever occurs last.
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Original Primary Outcome Measures ICMJE |
Progression Free Survival [ Time Frame: Every 6 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer | |||
Official Title ICMJE | A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant. | |||
Brief Summary | The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant. | |||
Detailed Description | This multicentre, open-label, randomised, Phase III study will enrol 764 patients with advanced breast cancer who have previously been treated with or are resistant to an anthracycline and who are taxane resistant. Patients will be randomised in a 1:1 ratio to receive vinflunine plus capecitabine (Arm A) or capecitabine alone (Arm B). Randomisation will be stratified according to a minimization procedure:
Patients randomised in Arm A will receive:
For patients randomised in Arm B, capecitabine will be self administered by the patient in an outpatient setting. Patients will take 1250 mg/m² twice daily per os for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. A cycle of therapy is defined as 3 weeks. The doses and timing of treatment will be modified based on toxicities experienced by the patient. Patients will be assessed for toxicity, tumour response and progression at regular intervals during treatment. Patients will be evaluated for safety if they received any study drug. Laboratory values, adverse events and other symptoms will be graded. Tumour response, progression-free survival and duration of response will be evaluated for all randomised patients. Tumour assessment is to be performed every 6 weeks (+/- 3 working days) from randomisation (regardless of the timing of treatment cycles) until disease progression is documented. Patients who discontinue protocol treatment for reasons other than disease progression will have tumour assessments every 6 weeks until documented disease progression. Patients may continue to receive additional cycles of therapy until progressive disease or intolerable toxicity. Quality of Life assessment, will be measured by EORTC QLQ-C30 and QLQ-BR23 questionnaires, which will be completed by patients. The primary endpoint for the trial is progression free survival calculated from the date of randomization until the date of progression or the date of death whatever the reason of death. The analysis of Progression-Free Survival is planned to take place when 615 progressions or deaths have been observed. One interim safety analysis is planned and will take place when 50 patients of each arm have completed at least one cycle of study treatment. It is anticipated that up to 170 active study centres will participate, and that accrual will be completed in approximately 30 months. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Martin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
770 | |||
Original Estimated Enrollment ICMJE |
764 | |||
Actual Study Completion Date ICMJE | October 2015 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Belarus, Belgium, Brazil, Bulgaria, Czechia, Estonia, France, Hungary, India, Italy, Mexico, Poland, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01095003 | |||
Other Study ID Numbers ICMJE | L00070 IN 305 B0 2008-004171-21 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Pierre Fabre Medicament | |||
Original Responsible Party | Jean-Claude VEDOVATO, Pierre Fabre Medicament | |||
Current Study Sponsor ICMJE | Pierre Fabre Medicament | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pierre Fabre Medicament | |||
Verification Date | April 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |