K105 Phase II Clinical trial (Breast cancer)
- Conditions
- Advanced or recurrent breast cancer
- Registration Number
- JPRN-jRCT2080223812
- Lead Sponsor
- ippon Kayaku Co., Ltd.
- Brief Summary
Weekly NK105 (80 mg/m2) administration was well-tolerated. Efficacy was similar in the NK105 group and the PTX group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 125
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall response rate (ORR)<br>ORR will be assessed according to RECIST version 1.1.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>Efficacy: Progression Free Survival (PFS), Overall Survival (OS), Time to Progression (TTP), Time to Treatment Failure (TTF)<br>Safety will be assessed according to CTCAE Ver. 4.03<br>Pharmacokinetics: Cmax and Ctrough of paclitaxel