Breast Neoplasms
Conditions
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 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.
Interventions
DRUGPemetrexed + Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8) * Pemetrexed (500 mg/m2, day 1)
DRUGVinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | response assessment every 6 weeks, for up to 2 years | From date of first dose of study drug till the date of documented progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response rate | response assessment every 6 weeks, for up to 2 years | Proportion of patients with objective response by RECIST version 1.1 |
| duration of response | response assessment every 6 weeks, for up to 2 years | Time from documentation of tumor response to disease progression |
| overall survival | up to 2 years | From date of first dose of study drug till the date of death from any cause |
Countries
South Korea
Outcome results
None listed