Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT01091168 |
Recruitment Status :
Completed
First Posted : March 23, 2010
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | February 3, 2010 | |||
First Posted Date ICMJE | March 23, 2010 | |||
Results First Submitted Date ICMJE | May 27, 2019 | |||
Results First Posted Date ICMJE | September 16, 2019 | |||
Last Update Posted Date | September 16, 2019 | |||
Actual Study Start Date ICMJE | July 2009 | |||
Actual Primary Completion Date | August 27, 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: From baseline up to 3 years 1 month ] 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.
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Original Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: monthly for 6 months after disease progression and then every 3 months ] | |||
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 Versus Alkylating Agent in Metastatic Breast Cancer | |||
Official Title ICMJE | 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) | |||
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. | |||
Detailed Description | Breast cancer is the most frequently diagnosed cancer in women worldwide and the second leading cause of cancer-related deaths in women. Patients with metastatic breast cancer (MBC) remains incurable, and current goals of therapy are to ameliorate symptoms, delay disease progression, improve or at least maintain quality of life (QoL), and prolong overall survival (OS).There are a number of agents with established single-agent activity, with the anthracyclines and taxanes considered generally the most active. In addition, several drugs with different mechanisms of action such as antimetabolites and vinca-alkaloids have also demonstrated substantial activity in the metastatic setting as single-agents or in combination. In patients who progress after having received anthracyclines, taxanes, antimetabolites and vinca- alkaloids, therapeutic options are scarce. In this heavily pretreated population for whom overall survival is not expected to exceed 6 to 7 months, there is a clear need for novel therapies. Vinflunine (VFL) is a microtubule inhibitor obtained by semi-synthesis, interacts with tubulin at the vinca-binding domain and inhibits tubulin assembly by perturbing microtubule dynamics and mitotic spindles without affecting assembled microtubules. VFL antitumour activity was fully demonstrated against a large and varied panel of murine and xenograft models. The main haematological toxicity reported was the neutropenia Grade 3-4 (40-50%). The incidence of its complications (febrile neutropenia and neutropenic infection) was less than 8%. The main non-haematological toxicity Grade 3-4 (with an incidence more than 10%) reported were constipation and fatigue. This was a prospective multicentre, open-label, randomised (1:1), phase III study comparing OS in patients treated with vinflunine versus those treated with an alkylating agent of physician's choice as third line treatment or more for patients with locally recurrent and/or metastatic breast cancer previously treated with and no longer candidate to anthracyclines, antimetabolites, taxanes and vinca- alkaloids.. The primary endpoint for the trial was OS. Patients were assessed for toxicity, tumour response and progression and status (alive-dead) at regular intervals during the study treatment and the follow-up period. Patients were treated until disease progression, unacceptable toxicity, patient or investigator's decision. After the study treatment discontinuation, patients were followed until death. The VFL dose of 280 mg/m² was the selected dose for this phase III study in patients with heavily pre- treated MBC. Indeed, VFL dose was reduced from 320 to 280 mg/m² in advanced transitional cell carcinoma of urothelial tract patients with performance status (PS) of 1 or with PS of 0 and having received prior pelvic irradiation. This dose was more regularly tolerable in patients with advanced disease stage who were heavily pre-treated. |
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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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* 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 |
594 | |||
Original Estimated Enrollment ICMJE |
586 | |||
Actual Study Completion Date ICMJE | January 2014 | |||
Actual Primary Completion Date | August 27, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:(main conditions)
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (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, Austria, Belarus, Belgium, France, Germany, Italy, Portugal, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01091168 | |||
Other Study ID Numbers ICMJE | L00070 IN 308 B0 | |||
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 | Maud BRANDELY, MD, 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 | August 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |