UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009046 |
|---|---|
| Receipt number | R000010611 |
| Scientific Title | Phase1 Study of nab-paclitaxel plus Cyclophosphamide in Metastatic Breast Cancer |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2014/10/20 14:57:30 |
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Basic information
Public title
Phase1 Study of nab-paclitaxel plus Cyclophosphamide in Metastatic Breast Cancer
Acronym
ABC-BC01
Scientific Title
Phase1 Study of nab-paclitaxel plus Cyclophosphamide in Metastatic Breast Cancer
Scientific Title:Acronym
ABC-BC01
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose(MTD) and the recommended dose(RD)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
maximum tolerated dose(MTD) and the recommended dose(RD)
Key secondary outcomes
Safety and Response Rate
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 180mg/m2-220mg/m2 Day1
cyclophosphamide 600mg/m2 Day1
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. Histological and/or cytological confirmed breast cancer
2. Metastatic breast cancer
3. Prior chemotherapy is up to 1 regimen
4. HER2 negative by IHC or FISH
5. ECOG performance status: 0-1
6. No clinical abnormality by electrocardiography.
7. Adequate organ function
8. Women aged 20 and over
9. Expected survival longer than 3 months
10. Written informed consent to participate
Key exclusion criteria
1. Patients with any history of serious drug reactions
2. Anamnesis of hypersensitivity to nab-paclitaxel and Cyclophosphamide
3. Active double cancer
4. Use of radiation or pre-and/or post-surgical cytotoxic drug within 3weeks before registration
5. Past radiotherapy more than 30% of hematopoietic bone marrow
6. Patients with serious complications
7. Serious peripheral neuropathy
8. Brain metastasis with symptom or brain metastasis needs medical treatment
9. Storage of pericardium liquid or storage of pleural effusion or ascites which needs drainage
10. With pregnancy, lactation or the possibility of pregnancy
11. Unsuitable judgement by physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Kutomi |
Organization
Sapporo Medical University
Division name
First Department of Surgery
Zip code
Address
South 1 West 16, Chuou-ku, Sapporo, Hokkaido
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Kutomi |
Organization
Sapporo Medical University
Division name
First Department of Surgery
Zip code
Address
South 1 West 16, Chuou-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
Sponsor or person
Institute
Sapporo Medical 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
札幌医科大学、札幌ことに乳腺クリニック、札幌乳腺外科クリニック、市立室蘭総合病院、東札幌病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 08 | 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 | 10 | Month | 05 | Day |
Last modified on
| 2014 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010611
