Advanced or recurrent breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : NK105
INN of investigational material : -
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for
Sponsors
Nippon Kayaku Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Histologically confirmed advanced or recurrent invasive breast cancer. - An Eastern Cooperative Oncology Group performance status score of 0 or 1. - At least one measurable lesion by Response Evaluation Criteria in Solid Tumors Version 1.1.
Exclusion criteria
Exclusion criteria: - Recurrence of breast cancer within 1 year after the last dose of a taxane-based chemotherapy regimen as neo-adjuvant and/or adjuvant therapy. - Prior treatment with a taxane-based chemotherapy regimen for advanced or recurrent breast cancer. - Prior chemotherapy with two or more regimens for advanced or recurrent breast cancer. - Eligible for anti-HER2 therapy. - Eligible for hormone monotherapy - Grade2 or greater peripheral sensory neuropathy or Grade1 or greater peripheral sensory neuropathy in the presence of diabetes. - Brain metastases with central nervous system symptoms or requiring treatment. - Active multiple cancers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall response rate (ORR) ORR will be assessed according to RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Efficacy: Progression Free Survival (PFS), Overall Survival (OS), Time to Progression (TTP), Time to Treatment Failure (TTF) Safety will be assessed according to CTCAE Ver. 4.03 Pharmacokinetics: Cmax and Ctrough of paclitaxel | — |
Countries
Japan
Outcome results
None listed