A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer

NCT02054338 | Terminated Phase 3 Results DMC

• 2 other identifiers: L00070 IN 303 B02006-001139-23
• Study Type: interventional
• Target: 1,004
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival

  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)

• Overall Response Rate & Disease Control Rate

  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

Study Arms (2)

vinflunine plus gemcitabine

EXPERIMENTAL

vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks

Drug: Vinflunine+Gemcitabine

paclitaxel plus gemcitabine

ACTIVE COMPARATOR

paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks

Drug: Paclitaxel+Gemcitabine

Interventions

Vinflunine+Gemcitabine DRUG

Vinflunine 320 mg/m² IV on day 1 and.Gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks

Also known as: L0070 IN

vinflunine plus gemcitabine

Paclitaxel+Gemcitabine DRUG

paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1

paclitaxel plus gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Limitations and Caveats

None reported

Results Point of Contact

• Title: Karim Keddad
• Organization: Institut de Recherche Pierre Fabre

karim.keddad@pierre-fabre.com

+33 5 34 50 61 69

Study Officials

• Karim Keddad, MD, PhD

  Employed Pierre Fabre Medicament

  STUDY DIRECTOR

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: January 31, 2014
• First Posted: February 4, 2014
• Study Start: June 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2015
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08