Status:
COMPLETED
PemVin vs Vin in Previously Treated Metastatic Breast Cancer
Lead Sponsor:
Seoul National University Hospital
Conditions:
Breast Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- histologically confirmed, recurrent or metastatic breast cancer
- HER2-negative
- ECOG PS 0-2
- Age ≥ 20 years
- Anthracycline- and Taxane-pretreated
- Wash-out period of 3 weeks for cytotoxic chemotherapy
- Wash-out period of 2 weeks for hormone therapy or radiotherapy
- measurable or non-measurable lesions by RECIST v1.1
- Adequate hematological functions : ANC ≥1,500/mm3, Platelet ≥100,000/mm3, Hb≥ 9g/dL
- Adequate liver functions
- Adequate renal functions : sCr≤1.5mg/dL
- Subjects willing to follow study protocol
- Informed consent before study entry
Exclusion
- More than 3 lines of chemotherapy for metastatic breast cancer
- Pregnant or breastfeeding women
- Previous exposure to Pemetrexed or Vinorelbine
- Neuropathy (grade 2 or more)
- Symptomatic CNS metastasis
- 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)
- Hypersensitivity to study medication or related drugs
- Concomitant vaccination for yellow fever
Key Trial Info
Start Date :
February 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03242616
Start Date
February 17 2017
End Date
April 15 2024
Last Update
April 17 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080