PemVin vs Vin in Previously Treated Metastatic Breast Cancer

NCT03242616 | Completed Phase 2

• 1 other identifier: H1607-172-780
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• progression free survival

  From date of first dose of study drug till the date of documented progression or death from any cause

  response assessment every 6 weeks, for up to 2 years

Secondary Outcomes (3)

• response rate

  response assessment every 6 weeks, for up to 2 years

• duration of response

  response assessment every 6 weeks, for up to 2 years

• overall survival

  up to 2 years

Study Arms (2)

Pemetrexed + Vinorelbine

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Drug: Vinorelbine

Interventions

Pemetrexed + Vinorelbine DRUG

Vinorelbine (25 mg/m2, day 1 \& 8) * Pemetrexed (500 mg/m2, day 1)

Pemetrexed + Vinorelbine

Vinorelbine DRUG

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

Vinorelbine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pemetrexed; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 8, 2017
• Study Start: February 17, 2017
• Primary Completion: December 5, 2023
• Study Completion: April 15, 2024
• Last Updated: April 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)