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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008861
Receipt No. R000010404
Scientific Title Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)
Date of disclosure of the study information 2012/09/05
Last modified on 2019/01/08

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Basic information
Public title Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)
Acronym Phase II study of weekly nanoparticle albumin-bound paclitaxel (KSCOG-BC04)
Scientific Title Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)
Scientific Title:Acronym 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
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School
of Medicine
Division name Department of Surgery
Zip code
Address 67 Asahi-machi,Kurume city,Fukuoka
TEL 0942-31-7566
Email utoh@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toh Uhi
Organization Kurume University School
Division name Department of Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 06 Month 20 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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