UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)
Title of the study (Brief title)	Phase II study of weekly nanoparticle albumin-bound paclitaxel (KSCOG-BC04)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of weekly nab-paclitaxel therapy for metastatic breast cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response Rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nab-paclitaxel 100mg/m2 on days 1, 8, 15 <HER2 positive> Nab-paclitaxel 100mg/m2 on days 1, 8, 15 Trastuzumab* : 2mg/kg , Day 1, 8, 15, 22 *4 mg/kg for the initial dosing (day 1) Cycles are repeated every 4 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) Written informed consent to participate 2) Suitable judgement by physician 3) Histological and/or cytological confirmed breast cancer 4) Metastatic breast cancer 5) The below criteria are met about prior therapy a. chemotherapy: more than 14 days passed after prior chemotherapy. b. hormonal therapy: more than 7 days passed after hormonal therapy c. radiation: more than 14 days passed after radiation. 6) Age 20 or over 7) Performance status (ECOG) 0-2 8) Has measurable lesion with CT within 28 days according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 9) The below criteria met within 14 days prior to therapy 1.WBC between 3,000/mm3 and 12,000/mm3 2.Granulocyte count 1,500/mm3 or over 3.Platelet count 100,000/mm3 or over 4.Hb 9.0 g/dl or over 5.Total bilirubin 2.0 mg/dL or under 6.AST(GOT) 100 IU/L or under 7.ALT(GPT) 100 IU/L or under 8.Serum creatinine 1.5 mg/dl or under 9.(only HER2 positive) Left ventricle ejection fraction 55 % or over by cardiac sonography or MUGA scan 10) Expected survival longer than 3 months
Key exclusion criteria	1) Anamnesis of hypersensitivity to drugs(especially paclitaxel or albumin) 2) Ttreatment history of taxanes (paclitaxel or docetaxel) for metastatic breast cancer 3)Peripheral neuropathy Grade2 or over 4) Pregnancy, or suspected pregnancy 5)Severe Infection (38 degrees or over) 6)Severe complication (interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes, uncontrolled hypertension and so on) 7) ECG abnormalities 8)Heart failure with clinically problem (cardiac failure, cardiac infarction, angina, cardiac valvulopathy) 9) Active secondary malignancy within 5 years of disease free interval(but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer by endoscopic mucosal resection) 10)Pleural effusion, ascites, and pericardial effusion that need treat 11) Symptomatic brain metastasis 12)Consecutive systemic administration of steroids 13)Physician judged improper to entry this trial
Target sample size	55

Research contact person
Name of lead principal investigator	Toh Uhi
Organization	Kurume University School of Medicine
Division name	Department of Surgery
Address	67 Asahi-machi,Kurume city,Fukuoka
TEL	0942-31-7566
Email	utoh@med.kurume-u.ac.jp

Public contact
Name of contact person	Toh Uhi
Organization	Kurume University School
Division name	Department of Surgery
Address	67 Asahi-machi
TEL	0942-31-7566
Homepage URL
Email	utoh@med.kurume-u.ac.jp

Sponsor
Institute	Department of Surgery, Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Kurume University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 06 Month 20 Day
Anticipated trial start date	2011 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 05 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010404