PemVin vs Vin in Previously Treated Metastatic Breast Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Pemetrexed + Vinorelbine; Drug: Vinorelbine

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 doseDexa 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
response rate	Proportion of patients with objective response by RECIST version 1.1	response assessment every 6 weeks, for up to 2 years
duration of response	Time from documentation of tumor response to disease progression	response assessment every 6 weeks, for up to 2 years
overall survival	From date of first dose of study drug till the date of death from any cause	up to 2 years

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine; Pemetrexed
• Other Study ID Numbers: H1607-172-780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No