Phase 3
Completed N=594
Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01091168 ↗Enrolled (actual)
594
Serious AEs
25.2%
Results posted
Sep 2019
Primary outcomePrimary: Overall Survival — 9.1; 9.3 Months — p=0.673
◆ Published Evidence
Emerging
10citations · ~1 / year
Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer.
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.
Linked Publications
-
Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
9.1; 9.3 | 0.673 |
| SECONDARY Disease Control Rate (DCR) |
43.6; 35.5 | 0.0424 sig |
| SECONDARY Progression Free Survival (PFS) |
2.5; 1.9 | 0.4927 |
Eligibility Criteria
Inclusion Criteria:(main conditions)
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01091168) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.