Advanced Breast Cancer Clinical Trial
— VICTORIAOfficial title:
Phase III Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer After Prior Anthracycline-based Adjuvant Chemotherapy
Verified date | August 2019 |
Source | Pierre Fabre Medicament |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to paclitaxel and gemcitabine is based on the following points: the significant antitumour activity of vinflunine in metastatic breast cancer (MBC) as single agent after anthracycline-taxane exposure and recent phase I study results of the vinflunine plus gemcitabine is at least additive and both drugs have a distinct mechanism of action; since taxanes have been approved in the adjuvant setting and are widely used in the treatment of early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first line therapy for metastatic breast cancer.
Status | Terminated |
Enrollment | 1004 |
Est. completion date | February 2015 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - female patients - 18 years or older but less than 75 years old - histologically/cytologically confirmed breast cancer - documented locally recurrent or metastatic breast cancer - HER-2 negative or unknown - prior neo- and/or adjuvant anthracycline-based chemotherapy - measurable or non-measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 - adequate haematological, hepatic and renal functions - ECG without any clinically relevant abnormality Exclusion Criteria: - known or clinical evidence of brain metastases or leptomeningeal involvement - history of second primary malignancy - patients having as sole tumour lesion: malignant effusion, lymphangitis, cystic lesion, bone lesion, and any other lesion not assessed by imaging techniques or colour photography - pre-existing motor/sensory grade > 1 peripheral neuropathy - prior therapy with vinca alkaloids and/or gemcitabine - history of severe hypersensitivity to vinca alkaloids and/or gemcitabine or contraindication to any of these drugs - pregnancy or breast feeding |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pierre Fabre Medicament |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | The primary efficacy parameter was Progression-free survival (PFS) analysed in the Intent-to-treat (ITT) population. PFS was defined as the time elapsed from randomisation date until the date of progression or death due to any cause (whichever came first).Tumor response was evaluated using the RECIST version 1.0 every 6 weeks until progression was recorded. | PFS was calculated from the registration date until the date of progression or death due to any cause if no progression was recorded first (median duration of follow-up: 14.1 months) | |
Secondary | Overall Survival | The secondary efficacy parameter was Overall Survival (OS) analysed in the Intent-to-treat (ITT) population. OS was defined as the time elapsed from the date of randomisation up to death or last follow-up. | OS was evaluated from the date of registration to the date of death due to any cause (median duration of follow-up: 14.1 months) | |
Secondary | Overall Response Rate & Disease Control Rate | Disease control rate (DCR) is defined as the sum of Complete Response (CR) and Partial Response (PR) and Stable Disease (SD) = 6 months rate. Objective response rate (ORR) is defined as the sum of Complete Response (CR) and Partial Response (PR) rate (using the best confirmed response recorded from the date of randomisation to the end of treatment). DCR and ORR, assessed by Independent Review Committee using RECIST 1.0, were calculated in the ITT population. | ORR and DCR were calculated from the date of randomisation of first patient until the database cut-off (30 June 2011), assessed up to 5 years |
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