Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
Phase III Trial of IV Vinflunine Versus an Alkylating Agent in Patients With Metastatic Breast Cancer Previously Treated With or Resistant to an Anthracycline, a Taxane, an Antimetabolite, and a Vinca-alkaloid (Study L00070 IN 308 B0)
1 other identifier
interventional
594
13 countries
76
Brief Summary
In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes, antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs, therapeutic options are very limited. Alkylating agents showed a modest activity in pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.
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 Jul 2009
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
September 16, 2019
CompletedSeptember 16, 2019
August 1, 2019
3.2 years
February 3, 2010
May 27, 2019
August 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.
From baseline up to 3 years 1 month
Secondary Outcomes (2)
Disease Control Rate (DCR)
From baseline up to 3 years 1 month
Progression Free Survival (PFS)
From baseline to cut-off date(27 August 2012), up to 3 years
Study Arms (2)
arm A: Vinflunine
EXPERIMENTALPatients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.
arm B: Alkylating agent of physician choice
ACTIVE COMPARATORPatients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.
Interventions
280 mg/m2 on day 1 of each cycle every 3 weeks
cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin
Eligibility Criteria
You may qualify if:
- Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,
- Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.
You may not qualify if:
- Concurrent serious uncontrolled medical disorder,
- known or clinical evidence of brain metastases or leptomeningeal involvement,
- pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,
- history of second primary malignancy,
- HIV infection, preexisting neuropathy,
- pregnancy or breast feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Unknown Facility
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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Graz, Austria
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Salzburg, Austria
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Vienna, Austria
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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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Haine-Saint-Paul, Belgium
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Yvoir, Belgium
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Angers, France
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Brest, France
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Clermont-Ferrand, France
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Dijon, France
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Grenoble, France
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Le Mans, France
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Lille, France
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Limoges, France
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Lorient, France
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Montpellier, France
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Nancy, France
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Nantes, France
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Nice, France
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Paris, France
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Pontoise, France
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Reims, France
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Rouen, France
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Saint-Brieuc, France
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Saint-Priest-en-Jarez, France
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Strasbourg, France
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Berlin, Germany
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Dortmund, Germany
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Essen, Germany
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Mainz, Germany
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Munich, Germany
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Trier, Germany
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Ancona, Italy
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Aviano, Italy
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Bolzano, Italy
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Brindisi, Italy
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Frattamaggiore, Italy
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Macerata, Italy
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Orbassano, Italy
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Lisbon, Portugal
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Arkhangelsk, Russia
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Engel's, 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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Volgograd, Russia
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Durban, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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A Coruña, Spain
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Barcelona, Spain
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Madrid, Spain
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Seville, Spain
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Dnipropetrovsk, Ukraine
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Kharkiv, Ukraine
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Khmelnytskyi, Ukraine
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Kyiv, Ukraine
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Burnley, United Kingdom
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Cornwell, United Kingdom
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Derby, United Kingdom
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Glasgow, United Kingdom
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Ipswich, United Kingdom
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Preston, United Kingdom
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Worthing, United Kingdom
Related Publications (1)
Cortes J, Perez-Garcia J, Levy C, Gomez Pardo P, Bourgeois H, Spazzapan S, Martinez-Janez N, Chao TC, Espie M, Nabholtz JM, Gonzalez Farre X, Beliakouski V, Roman Garcia J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051.
PMID: 29481630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Karim Keddad
- Organization
- INSTITUT DE RECHERCHE PIERRE FABRE
Study Officials
- STUDY DIRECTOR
Karim Keddad, MD, PhD
Institut de Recherche Pierre Fabre
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
February 3, 2010
First Posted
March 23, 2010
Study Start
July 1, 2009
Primary Completion
August 27, 2012
Study Completion
January 1, 2014
Last Updated
September 16, 2019
Results First Posted
September 16, 2019
Record last verified: 2019-08