JPRN-jRCT2080223812CompletedPhase 2
A Randomized Phase II Trial Comparing NK105 and Paclitaxel in Advanced or Recurrent Breast Cancer
ippon Kayaku Co., Ltd.0 sites125 target enrollmentStarted: February 16, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 125
Study Overview
Brief Summary
Weekly NK105 (80 mg/m2) administration was well-tolerated. Efficacy was similar in the NK105 group and the PTX group.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 74age old (—)
- Sex
- Female
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
- •- 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.
Investigators
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