Breast NeoplasmsPhase 2NCT03242616
PemVin vs Vin in Previously Treated Metastatic Breast Cancer
A Phase 2 study testing Pemetrexed + Vinorelbine and Vinorelbine in people with Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Pemetrexed + Vinorelbine and Vinorelbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Feb 2017to 15 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Breast Neoplasms
- Being tested
- Pemetrexed + Vinorelbine, Vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed + VinorelbineDrug
Vinorelbine (25 mg/m2, day 1 \& 8)
- Pemetrexed (500 mg/m2, day 1)
VinorelbineDrug
Vinorelbine (25 mg/m2, day 1 \& 8)
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed + Vinorelbine | Experimental | 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 Receives: Drug: Pemetrexed + Vinorelbine |
| Vinorelbine | Active comparator | Vinorelbine (25 mg/m2, day 1 \& 8) Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
From date of first dose of study drug till the date of documented progression or death from any cause
Measured: response assessment every 6 weeks, for up to 2 years
Secondary outcomes (3)
response rate
Proportion of patients with objective response by RECIST version 1.1
Measured: response assessment every 6 weeks, for up to 2 years
duration of response
Time from documentation of tumor response to disease progression
Measured: response assessment every 6 weeks, for up to 2 years
overall survival
From date of first dose of study drug till the date of death from any cause
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start17 Feb 2017
- Primary completion5 Dec 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seock-Ah Im, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242616
- Sponsor's protocol ID
- H1607-172-780
- Status last verified
- Dec 2024
- First submitted
- 28 Jul 2017
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03242616
- Acronym / sponsor ID
- H1607-172-780
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed + Vinorelbine | Experimental | Drug: Pemetrexed + VinorelbineVinorelbine (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 |
| Vinorelbine | Active comparator | Drug: VinorelbineVinorelbine (25 mg/m2, day 1 \& 8) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- histologically confirmed, recurrent or metastatic breast cancer
- HER2-negative
- ECOG PS 0-2
- Age ≥ 20 years
- Anthracycline- and Taxane-pretreated
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemetrexed + VinorelbineVinorelbine (25 mg/m2, day 1 \& 8) * Pemetrexed (500 mg/m2, day 1) | Drug | Pemetrexed + Vinorelbine |
| VinorelbineVinorelbine (25 mg/m2, day 1 \& 8) | Drug | Vinorelbine |
Primary outcome
progression free survival
Time frame: 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
3 secondary outcomes
response rate
Time frame: response assessment every 6 weeks, for up to 2 years
duration of response
Time frame: response assessment every 6 weeks, for up to 2 years
overall survival
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed + Vinorelbine and Vinorelbine in people with Breast Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: response assessment every 6 weeks, for up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.