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Completed

NCT Number: NCT03242616

PemVin vs Vin in Previously Treated Metastatic Breast Cancer

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed + Vinorelbine

Drug

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

  • Pemetrexed (500 mg/m2, day 1)

Vinorelbine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Aug 8, 2017
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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