PemVin vs Vin in Previously Treated Metastatic Breast Cancer

NCT ID: NCT03242616

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2024-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pemetrexed + Vinorelbine

Intervention Type: DRUG

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

• Pemetrexed (500 mg/m2, day 1)

Vinorelbine

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

Group Type: ACTIVE_COMPARATOR

Vinorelbine

Intervention Type: DRUG

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

Interventions

Pemetrexed + Vinorelbine

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

• Pemetrexed (500 mg/m2, day 1)

Intervention Type: DRUG

Vinorelbine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seock-Ah Im

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

H1607-172-780

Identifier Type: -

Identifier Source: org_study_id