PemVin vs Vin in Previously Treated Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Pemetrexed + Vinorelbine; Drug: Vinorelbine

• Registration Number: NCT03242616
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Primary Completion: 2023-12-05
• Study Completion: 2024-04-15
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pemetrexed + Vinorelbine	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
Vinorelbine	Vinorelbine	Vinorelbine (25 mg/m2, day 1 \& 8)

Primary Outcome Measures

Name	Time	Method
progression free survival	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

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of