Clinical trial · Interventional
PemVin vs Vin in Previously Treated Metastatic Breast Cancer
Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane
- 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)
Pemetrexed is a multi-targeted anti-folate, that is used for non-small cell lung cancer and mesothelioma. There are several clinical studies of pemetrexed in breast cancer, but these are largely done before the wide use of premedication (steroid and vitamin B12) for pemetrexed. Moreover, it has not been studied in combination with vinorelbine, which is a commonly used drug for anthracycline- and taxane-pretreated metastatic breast cancer. This is a randomized phase II study of pemetrexed plus vinorelbine versus vinorelbine in patients with recurrent or metastatic breast cancer previously treated with or resistant to an anthracycline and taxane.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed + Vinorelbine | Drug | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Vinorelbine
- description
- Vinorelbine (25 mg/m2, day 1 \& 8) * Pemetrexed (500 mg/m2, day 1) 1. Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.) 2. Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose 3. Dexa 4mg po bid on D0-2
- interventionNames
- Drug: Pemetrexed + Vinorelbine
- type
- ACTIVE_COMPARATOR
- label
- Vinorelbine
- description
- Vinorelbine (25 mg/m2, day 1 \& 8)
- interventionNames
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically confirmed, recurrent or metastatic breast cancer 2. HER2-negative 3. ECOG PS 0-2 4. Age ≥ 20 years 5. Anthracycline- and Taxane-pretreated 6. Wash-out period of 3 weeks for cytotoxic chemotherapy 7. Wash-out period of 2 weeks for hormone therapy or radiotherapy 8. measurable or non-measurable lesions by RECIST v1.1 9. Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL 10. Adequate liver functions 11. Adequate renal functions : sCr≤1.5mg/dL 12. Subjects willing to follow study protocol 13. Informed consent before study entry Exclusion Criteria: 1. More than 3 lines of chemotherapy for metastatic breast cancer 2. Pregnant or breastfeeding women 3. Previous exposure to Pemetrexed or Vinorelbine 4. Neuropathy (grade 2 or more) 5. Symptomatic CNS metastasis 6. History of malignant disease within 5 years (except for cured basal cell cancer or squamous cell cancer of skin, cured thyroid cancer, in-situ cervical cancer) 7. Hypersensitivity to study medication or related drugs 8. Concomitant vaccination for yellow fever
References
Publications (0)
Data not yet available