PemVin vs Vin in Previously Treated Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT03242616 |
Recruitment Status : Unknown
Verified August 2017 by Seock-Ah Im, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms | Drug: Pemetrexed + Vinorelbine Drug: Vinorelbine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 17, 2017 |
Estimated Primary Completion Date : | December 31, 2019 |
Estimated Study Completion Date : | December 31, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed + Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
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Drug: Pemetrexed + Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
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Active Comparator: Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
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Drug: Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8) |
- 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
- response rate [ Time Frame: response assessment every 6 weeks, for up to 2 years ]Proportion of patients with objective response by RECIST version 1.1
- duration of response [ Time Frame: response assessment every 6 weeks, for up to 2 years ]Time from documentation of tumor response to disease progression
- overall survival [ Time Frame: up to 2 years ]From date of first dose of study drug till the date of death from any cause

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242616
Contact: Seock-Ah Im | 82-2-2072-0850 | moisa@snu.ac.kr | |
Contact: Kyung-Hun Lee | 82-2-2072-7207 | kyunghunlee@snu.ac.kr |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Contact: Seock-Ah Im 82-2-2072-0850 moisa@snu.ac.kr |
Responsible Party: | Seock-Ah Im, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT03242616 |
Other Study ID Numbers: |
H1607-172-780 |
First Posted: | August 8, 2017 Key Record Dates |
Last Update Posted: | August 8, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Pemetrexed Vinorelbine Antineoplastic Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |