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Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer

Not Applicable
Recruiting
Conditions
Breast cancer
Registration Number
JPRN-UMIN000005982
Lead Sponsor
Wakayama Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

1) Allergy of nab-paclitaxel, albumin or paclitaxel 2) Serious complication 3) Synchronous or metachronous (within 5 years) double cancers 4) Abnormal ECG 5) Congestive heart failure, coronary artery diseases, uncontrollable arrhythmia or past history of myocardial infarction or angina pectoris within 6 months 6) Relapsed within 12 months (or during its treatment) after taxane-based neoadjuvant and adjuvant chemotherapy. Resistant to taxane-based neoadjuvant chemotherapy 7) Fully recovered from surgical within 4 weeks before registration 8) Received radiotherapy or neoadjuvant and adjuvant chemotherapy within 3 weeks before registration 9) Received endocrine therapy within 2 weeks before registration 10) Received ratiotherapy for more than 30% of hematopoietic bone marrow 11) Peripheral neuropathy grade 2 or greater 12) Active infection 13) Symptomatic brain metastasis 14) Un-controlled pleural effusion and ascites 15) Long-term corticosteroid therapy 16) Mental disorder 17) Pregnancy, breast feeding or wish of future bearing 18) Patients considered inappropriate by the study investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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