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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004573

Enrollment

125

Registered

2019-12-20

Start date

2017-02-27

Completion date

Unknown

Last updated

2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Subjects will be randomized and assigned to one of the two groups below. Arm 1: vinorelbine (25 mg / m2, Days 1 & 8) Arm 2: pemetrexed (500 mg / m2, Day 1) + vinorelbine (25 mg / m2, Days 1 & 8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Recurrent breast cancer or metastatic (stage 4) breast cancer that is histologically confirmed without resection or radiotherapy 2. HER2 negative breast cancer. 3. ECOG Performance 0-2 4. Age = 20 years 5. Anthracycline (unless medically inappropriate or contraindicated), prior treatment with taxane 6. All previous chemotherapy should have been completed 3 weeks prior to the start of treatment. 7. Hormonal therapy or radiotherapy (including conventional purposes) must have been completed two weeks prior to the start of treatment. 8. If there is a target lesion measurable by RECIST v1.1 or a non-measurable non-target lesion 9. Hematologic function: Absolute neutrophil =1,500 / mm3, platelet =100,000 / mm3, hemoglobin = 9g / dL 10. Liver function: Total bilirubin = 1.5 x upper normal limit (UNL), alkaline phosphatase = 2.5 x upper limit, AST / ALT = 2 x upper limit (in case of liver metastases, AST / ALT = 2.5 x Normal upper limit, total bilirubin =3.0 mg / dL, alkaline phosphatase = 5 x normal upper limit, alkaline phosphatase = 5 x normal upper limit if multiple bone metastases are present) 11.Kidney function: Serum creatinine=1.5mg /dL 12. Willing and able to comply with the research protocol during the study. 13. A consent form must be obtained prior to enrollment in the study.

Exclusion criteria

Exclusion criteria: 1. History of more than 3 lines of anticancer drugs previously treated for metastatic breast cancer -Excludes hormone monotherapy or combination therapy with hormones -Included in cases of metastasis within 6 months of the end date of advanced chemotherapy and adjuvant chemotherapy 2. Pregnant or lactating women 3. History of Pemetrexed or Vinorelbine Previously 4. Current grade 2 or higher neuropathy 5. Symptomatic brain metastases 6. History of another malignant disease within the last five years (completely cured skin or squamous cell carcinoma, cured thyroid cancer and in-situ cervical cancer are acceptable). 7. Patients with hypersensitivity to the test drug or excipient component 8. Concurrent vaccination of yellow fever vaccine

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
response rate;response duration;overall survival;Toxicity;Quality of life	—

Countries

Korea, Republic of

Contacts

Public ContactEunkyung Kim

Seoul National University Hospital

Outcome results