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PemVin vs Vin in Previously Treated Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Pemetrexed + Vinorelbine Drug: Vinorelbine Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Pemetrexed + Vinorelbine

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

  • Pemetrexed (500 mg/m2, day 1)
Active Comparator: Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)
 Drug: Vinorelbine
Vinorelbine (25 mg/m2, day 1 & 8)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. duration of response [ Time Frame: response assessment every 6 weeks, for up to 2 years ]
    Time from documentation of tumor response to disease progression

  3. overall survival [ Time Frame: up to 2 years ]
    From date of first dose of study drug till the date of death from any cause


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Seock-Ah Im 82-2-2072-0850 moisa@snu.ac.kr
Contact: Kyung-Hun Lee 82-2-2072-7207 kyunghunlee@snu.ac.kr

Locations
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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   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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