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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
Sponsor:
Information provided by (Responsible Party):
Seock-Ah Im, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 8, 2017
Last Update Posted Date August 8, 2017
Actual Study Start Date  ICMJE February 17, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PemVin vs Vin in Previously Treated Metastatic Breast Cancer
Official Title  ICMJE 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
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Pemetrexed + Vinorelbine

    Vinorelbine (25 mg/m2, day 1 & 8)

    • Pemetrexed (500 mg/m2, day 1)
  • Drug: Vinorelbine
    Vinorelbine (25 mg/m2, day 1 & 8)
Study Arms  ICMJE
  • Experimental: Pemetrexed + Vinorelbine

    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
    Intervention: Drug: Pemetrexed + Vinorelbine
  • Active Comparator: Vinorelbine
    Vinorelbine (25 mg/m2, day 1 & 8)
    Intervention: Drug: Vinorelbine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 3, 2017)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242616
Other Study ID Numbers  ICMJE H1607-172-780
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seock-Ah Im, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP