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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020994
Receipt No. R000024236
Scientific Title Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Date of disclosure of the study information 2016/02/12
Last modified on 2016/10/17

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Basic information
Public title Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Acronym Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Scientific Title Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Scientific Title:Acronym Observational study of Nab-paclitaxel followed by Anthracycline based regimen as preoperative chemotherapy for ER-negative resectable primary breast cancer
Region
Japan

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

Objectives
Narrative objectives1 evaluate the efficacy and safety of the preoperative chemotherapy with nab-paclitaxel (with or without Trastuzumab) followed by Anthracycline based regimen for the ER-negative resectable primary breast cancer. To evaluate the relevance of expression of the molecular marker (Caveolin-1 (Cav1), SPARC) and therapeutic effects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pathological complete 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 Preoperative chemotherapy with nab-paclitaxel(with or without Trastuzumab) therapy 4 courses followed by Anthracycline based regimen four courses, to perform the surgery
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
75 years-old >
Gender Female
Key inclusion criteria 1)female breast cancer histologically diagnosed primary invasive breast cancer
2)stage2-3A
3) radical resection can be expected by preoperative chemotherapy and surgery
4)patients with measurable lesions
5)diagnosed ER-negative
6)20 years old or older, 75 years old or younger
7)performance Status (PS) 0-1
8)no previous treatment, surgery, radiation therapy, chemotherapy, endocrine therapy
9) LVEF values is determined to be proper (> 50%) by echocardiography or MUGA
10)major organ function is sufficiently held in the clinical examination of the registration within 14 days prior
11)consent is obtained from the patient himself in writing for the test participation
Key exclusion criteria 1)patients with previous treatment history of nab-paclitaxel
2)active double cancer (synchronous double cancer and metachronous double cancer disease-free period is within 5 years)
3)serious complications (congestiveheart failure, coronary insufficiency, heart disease such as a myocardial infarction and angina pectoris and Arrhythmia requiring treatment, history of cerebrovascular disease, gastrointestinal ulcer bleeding or requiring treatment, control bad diabetes, renal failure, active hepatitis and cirrhosis, liver failure, etc.)
4)has a fever, suspected infection
5)pleural effusion requiring treatment, pericardial effusion example
6)a clear interstitial pneumonia or pulmonary fibrosis in the chest X photos and chest CT
7)a history of drug hypersensitivity
8)a history of severe hypersensitivity for the components of the therapeutic agent (nab-paclitaxel)
9) a possibility of pregnancy and pregnancy, or breast-feeding
10)history of serious mental illness or are under treatment, patients judged that the participation in examination is difficult
11)HBs antigen-positive
12)Other cases of the physician has determined to be inappropriate as a target
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Yamagami
Organization SHINKO HOSPITAL
Division name Department of Breast Surgery
Zip code
Address 1-4-47, WAKINOHAMACHO, CHUO-KU, KOBE, 651-0072
TEL 078-261-6711
Email kazu.yama.-0825@shinkohp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Yamagami
Organization SHINKO HOSPITAL
Division name Department of Breast Surgery
Zip code
Address 1-4-47, WAKINOHAMACHO, CHUO-KU, KOBE, 651-0072
TEL 078-261-6711
Homepage URL
Email kazu.yama.-0825@shinkohp.or.jp

Sponsor
Institute SHINKO HOSPITAL
Institute
Department

Funding Source
Organization None
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
2016 Year 02 Month 12 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 Open public recruiting
Date of protocol fixation
2012 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 13 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
2016 Year 02 Month 12 Day
Last modified on
2016 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024236

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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