PemVin vs Vin in Previously Treated Metastatic Breast Cancer

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 31, 2019

Interventions

• 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)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Seoul National University Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Seock-Ah Im, Professor – Seoul National University Hospital
• Overall Contact(s)
  • Seock-Ah Im, 82-2-2072-0850, moisa@snu.ac.kr