UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007724 |
|---|---|
| Receipt number | R000009081 |
| Scientific Title | Primary systemic therapy of nab-paclitaxel in breast cancer patients |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2012/04/10 21:40:38 |
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Basic information
Public title
Primary systemic therapy of nab-paclitaxel in breast cancer patients
Acronym
PINC-BC study
Scientific Title
Primary systemic therapy of nab-paclitaxel in breast cancer patients
Scientific Title:Acronym
PINC-BC study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess the efficary and safety of FEC followed by Nab-paclitaxel as primary systemic therapy for breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Responce rate,Histological therapeutic effect,breast conserving rate after preoperative chemotherapy,Safety
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
4 cycles of FEC followed by 4 cycles of Nab-paclitaxel
FEC:Epi 100mg/m2 and CPA 500mg/m2 and 5-FU 500mg/m2,day1 every 3weeks
Nab-paclitaxel:260mg/m2,day1 every 3weeks
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
Female patients with
1)Histologically confirmed invasive breast cancer
2)Lymph node metastases
3)Radical cure by operation and neoadjuvant chemotherapy
4)PS 0-2
5)Age>=20
6)No prior treatment for breast cancer
7)Required baseline laboratory data within 14days of registration
Hb>=8.0g/dL
WBC>=3000/mm3 and <=12000mm3
Neu>=2000/mm3
Plt>=100000/mm3
T-Bil<=1.5mg/dL
AST,ALT<100IU/L
Cre<=1.5mg/dL
8)Not clinically significant heart disease
9)Written informed consent
Key exclusion criteria
1)Serious drug hypersensitivity
2)Other severe complications
3)Symptomatic brain metastasis
4)Active bleeding of digestive tract
5)Serious myeloablation,renal insufficciency,liver failure
6)Massive hydrothorax or ascites
7)Allergy of the Nab-paclitaxel,paclitaxelor albumin
8)Administration Pentostatin
9)Have any cances other than breast cancer
10)Active infection
11)Pregnant
12)Severe mental disorders
13)Administration steroid
14)Not suitable for participating in the study for any other reason
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nagashima |
Organization
Graduate school of medicine,Chiba University
Division name
Department of General Surgery
Zip code
Address
1-8-1 Inohana,Chuo-ku,Chiba,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Sakakibara |
Organization
Graduate school of medicine,Chiba University
Division name
Department of General Surgery
Zip code
Address
1-8-1 Inohana,Chuo-ku,Chiba,Japan
TEL
043-222-7171
Homepage URL
Sponsor or person
Institute
Graduate school of medicine,Chiba University
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
| 2012 | Year | 04 | Month | 10 | 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 | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2012 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009081
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
