PemVin vs Vin in Previously Treated Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Pemetrexed + Vinorelbine
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed + Vinorelbine<br>Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1) Actinamide 1mg IM: 1 week before 1st dose, q 9 weeks (1wk before 1st cycle, 4th,7th,10th…. cycle after then.) Folic acid 1mg daily: 1 week before 1st dose until 3 weeks after last dose Dexa 4mg po bid on D0-2 | Drug: Pemetrexed + Vinorelbine<br>* Vinorelbine (25 mg/m2, day 1 & 8) Pemetrexed (500 mg/m2, day 1)<br>|
| Active Comparator: Vinorelbine<br>Vinorelbine (25 mg/m2, day 1 & 8) | Drug: Vinorelbine<br>* Vinorelbine (25 mg/m2, day 1 & 8)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | From date of first dose of study drug till the date of documented progression or death from any cause | response assessment every 6 weeks, for up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | Proportion of patients with objective response by RECIST version 1.1 | response assessment every 6 weeks, for up to 2 years | 
| duration of response | Time from documentation of tumor response to disease progression | 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 | up to 2 years |