UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006597 |
|---|---|
| Receipt number | R000007807 |
| Scientific Title | Phase I trial of Albumin-bound paclitaxel plus Cyclophosphamide for metastatic breast cancer |
| Date of disclosure of the study information | 2011/10/24 |
| Last modified on | 2019/10/29 15:52:38 |
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Basic information
Public title
Phase I trial of Albumin-bound paclitaxel plus Cyclophosphamide for metastatic breast cancer
Acronym
Phase I trial of Albumin-bound paclitaxel plus Cyclophosphamide for metastatic breast cancer
Scientific Title
Phase I trial of Albumin-bound paclitaxel plus Cyclophosphamide for metastatic breast cancer
Scientific Title:Acronym
Phase I trial of Albumin-bound paclitaxel plus Cyclophosphamide for metastatic breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate maximum tolerated doze and recommended dose of Cyclophosphamide and Albumin-bound paclitaxel combination chemotherapy for metastatic breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To determinate maximum tolerated dose and recommended dose
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
Cyclophosphamide 600mg/m2 day1
Albumin-bound paclitaxel 150mg/m2 - 260mg/m2 day1
every 3 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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histological confirmed primary breast cancer
2) Clinically confirmed metastatic breast cancer
3) Age are 20-70 years old
4) ECOG performance status of 0 or 1
5) no effect remain from prior chemotherapy
6) Required baseline laboratory data(within 14 days of registration)
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Hb >= 9.0g/dL
Plt >= 100,000/mm3
T-Bil <= 1.5mg/dL
AST < 100 IU/L
ALT < 100 IU/L
Cre <= 1.5mg/dL
7) Expected survival time: more than 3 months
8) Written informed consent
Key exclusion criteria
1) allergy of the nab-paclitaxel, paclitaxel or albumin
2) allergy of the medication
3) HER2 positive confirmed by IHC 3+ or FISH+
4) During pregnancy or lactation
5) Severe infectious disease
6) Clinically significant heart disease
7) Uncontrollable pleural effusion or ascites requiring
8) Symptomatic brain metastasis
9) with active another cancer
10) Peripheral neuropathy grade 2 or greater
11) with pulmonary fibrosis or pneumonitis
12) Cases who physician judged improper to entry this trial
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Abe |
Organization
Shiga University of Medical Science
Division name
Division of Breast and General Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shiga University of Medical Science
Division name
Division of Breast and General Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Homepage URL
Sponsor or person
Institute
Shiga University of Medical Science
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
| 2011 | Year | 10 | Month | 24 | 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 | 21 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 23 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007807
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
