NCT03242616CompletedPhase 2
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 · Last updated 17 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 28 Jul 2017
- Start date
- 17 Feb 2017
- Primary completion date
- 5 Dec 2023
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03242616
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 17
- From 17 Feb 2017 to the primary completion date, 5 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to Pemetrexed or Vinorelbine
- Concomitant vaccination for yellow fever
Other illness
- More than 3 lines of chemotherapy for metastatic breast cancer
- 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
Other
- Pregnant or breastfeeding women
- Neuropathy (grade 2 or more)
- Symptomatic CNS metastasis
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.