UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020994 |
|---|---|
| Receipt number | 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 19:19:05 |
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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
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
kazu.yama.-0825@shinkohp.or.jp
Sponsor or person
Institute
SHINKO HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024236
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| Registered date | File name |
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