Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer
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.
2 other identifiers
interventional
770
19 countries
107
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started May 2009
Typical duration for phase_3 breast-cancer
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
September 13, 2019
CompletedApril 28, 2022
April 1, 2022
2.6 years
March 24, 2010
May 27, 2019
April 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
Baseline up to 2 years 7 months
Secondary Outcomes (4)
Overall Survival
Baseline upto 3 years 10 months
Overall Response Rate (ORR)
Baseline upto 2 years 7 months
Disease Control Rate
Baseline up to 2 years 7 months
Duration of Response
Baseline up to 2 years 7 months
Study Arms (2)
Vinflunine plus Capecitabine
EXPERIMENTALPatients received (in combination with capecitabine) • Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.
Capecitabine single-agent
ACTIVE COMPARATORCapecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).
Interventions
Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
Eligibility Criteria
You may qualify if:
- female patients
- years of age or older
- histologically/cytologically confirmed carcinoma of the breast
- documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
- either one, two or three prior chemotherapy regimens
- prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
- measurable or non-measurable disease according to RECIST 1.1
- Karnofsky performance score of at least 70 %
- adequate haematological, hepatic and renal functions
- ECG without clinically relevant abnormality
You may not qualify if:
- known or clinical evidence of brain metastasis or leptomeningeal involvement
- pulmonary lymphangitis or symptomatic pleural effusion
- any serious, concurrent uncontrolled medical disorder
- history of second primary malignancy
- preexisting motor/sensory peripheral neuropathy
- known history of HIV infection
- prior therapy with capecitabine and/or vinca-alkaloids
- history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
- known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
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Buenos Aires, Argentina
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Quilmes, Argentina
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Rosario, Argentina
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San Martín, Argentina
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San Miguel de Tucumán, Argentina
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Grodno, Belarus
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Homyel, Belarus
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Minsk, Belarus
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Vitebsk, Belarus
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Brussels, Belgium
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Liège, Belgium
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Curitiba, Brazil
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Porto Alegre, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Brno, Czechia
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Jihlava, Czechia
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Tallinn, Estonia
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Angers, France
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Caen, France
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Dijon, France
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Le Mans, France
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Lorient, France
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Lyon, France
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Montpellier, France
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Nantes, France
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Saint-Brieuc, France
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Saint-Cloud, France
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Saint-Herblain, France
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Tours, France
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Villejuif, France
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Budapest, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Aurangabad, India
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Bangalore, India
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Bhopal, India
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Calicut, India
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Jaipur, India
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Kolkata, India
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Mumbai, India
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Patna, India
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Pune, India
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Trivandrum, India
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Avellino, Italy
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Cagliari, Italy
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Cremona, Italy
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Fabriano, Italy
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Milan, Italy
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Monza, Italy
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Padua, Italy
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Pisa, Italy
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Rozzano, Italy
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Verona, Italy
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Chihuahua City, Mexico
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León, Mexico
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Mexico City, Mexico
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Saltillo, Mexico
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Bialystok, Poland
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Gdansk, Poland
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Krakow, Poland
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Lodz, Poland
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Lubin, Poland
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Warsaw, Poland
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Moscow, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Stavropol, Russia
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Tambov, Russia
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Ufa, Russia
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Vladimir, Russia
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Volgograd, Russia
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Kamenitz, Serbia
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Niš, Serbia
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Durban, South Africa
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Kimberley, South Africa
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Pretoria, South Africa
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Sandton, South Africa
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Barcelona, Spain
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Lleida, Spain
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Madrid, Spain
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Oviedo, Spain
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Valencia, Spain
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Genolier, Switzerland
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Lausanne, Switzerland
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Winterthur, Switzerland
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Cherkasy, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Khmelnytskyi, Ukraine
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Kyiv, Ukraine
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Simferopol, Ukraine
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Belfast, United Kingdom
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Chelmsford, United Kingdom
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Keighley, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Peterborough, United Kingdom
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Portsmouth, United Kingdom
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Sheffield, United Kingdom
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Southend-on-Sea, United Kingdom
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Sutton, United Kingdom
Related Publications (1)
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.
PMID: 29447329DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No limitations and caveats
Results Point of Contact
- Title
- Karim Keddad
- Organization
- Institut de Recherche Pierre Fabre
Study Officials
- STUDY DIRECTOR
Jean-Claude VEDOVATO
Pierre Fabre Medicament
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 29, 2010
Study Start
May 1, 2009
Primary Completion
December 1, 2011
Study Completion
October 1, 2015
Last Updated
April 28, 2022
Results First Posted
September 13, 2019
Record last verified: 2022-04