Clinical trial · Interventional
Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer
A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Vinflunine plus Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vinflunine plus Capecitabine
- description
- Patients received (in combination with capecitabine) • Vinflunine at the dose of 280 mg/m² and as a 20-minute IV. infusion on day 1 of each cycle repeated every 3 weeks.
- interventionNames
- Drug: Vinflunine plus Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine single-agent
- description
- Capecitabine at the dose of 825mg/m² per os twice per day each morning and each evening for 14 consecutive days beginning on day 1 of each cycle repeated every 3 weeks (self-administered).
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * female patients * 21 years of age or older * histologically/cytologically confirmed carcinoma of the breast * documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy * either one, two or three prior chemotherapy regimens * prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs * measurable or non-measurable disease according to RECIST 1.1 * Karnofsky performance score of at least 70 % * adequate haematological, hepatic and renal functions * ECG without clinically relevant abnormality Exclusion Criteria: * known or clinical evidence of brain metastasis or leptomeningeal involvement * pulmonary lymphangitis or symptomatic pleural effusion * any serious, concurrent uncontrolled medical disorder * history of second primary malignancy * preexisting motor/sensory peripheral neuropathy * known history of HIV infection * prior therapy with capecitabine and/or vinca-alkaloids * history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs * known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency * pregnancy or breast feeding
References
Publications (1)
- DERIVEDMartin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063. PMID 29447329