Clinical Trials /

PemVin vs Vin in Previously Treated Metastatic Breast Cancer

NCT03242616

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PemVin vs Vin in Previously Treated Metastatic Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: H1607-172-780
  • NCT ID: NCT03242616

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
Pemetrexed + VinorelbinePemetrexed + Vinorelbine
VinorelbineVinorelbine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pemetrexed + VinorelbineExperimentalVinorelbine (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
  • Pemetrexed + Vinorelbine
VinorelbineActive ComparatorVinorelbine (25 mg/m2, day 1 & 8)
  • Vinorelbine

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:response rate
Time Frame:response assessment every 6 weeks, for up to 2 years
Safety Issue:
Description:Proportion of patients with objective response by RECIST version 1.1
Measure:duration of response
Time Frame:response assessment every 6 weeks, for up to 2 years
Safety Issue:
Description:Time from documentation of tumor response to disease progression
Measure:overall survival
Time Frame:up to 2 years
Safety Issue:
Description:From date of first dose of study drug till the date of death from any cause

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seoul National University Hospital

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