Clinical trial · Interventional
A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was stopped before progressive disease or death of alive subjects.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel+Gemcitabine | Drug | — | UNRESOLVED |
| Vinflunine+Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- vinflunine plus gemcitabine
- description
- vinflunine 320 mg/m² D1 plus gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks
- interventionNames
- Drug: Vinflunine+Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- paclitaxel plus gemcitabine
- description
- paclitaxel 175 mg/m² D1 followed by Gemcitabine 1250 mg/m² D1 and D8 every 3 weeks
- interventionNames
- Drug: Paclitaxel+Gemcitabine
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available