UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000513 |
|---|---|
| Receipt number | R000000621 |
| Scientific Title | Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression |
| Date of disclosure of the study information | 2006/11/06 |
| Last modified on | 2017/11/30 18:02:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression
Acronym
Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression
Scientific Title
Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression
Scientific Title:Acronym
Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression
Region
| Japan |
Condition
Condition
Inflammatory breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate treatment results when inflammatory breast cancer with HER2 over expression patients were treated by chemotherapy (AC-T with trastuzumab) and radiotherapy (CRT) alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
TTP (Time To Progression)
Key secondary outcomes
Overall survival
Toxicity
Clinical response rate
Pathological 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
The chemotherapy of AC consisted of 60mg/m2 of doxorubicin and 600mg/m2 of cyclophosphamide every 21 days four cycles. Paclitaxel dose of 80 mg/m2 was given weekly for 12 weeks and trastuzumab for 52 weeks.
Whole-breast radiotherapy with an optional boost was initiated after the completion of chemotherapy whose total dose was 5000 to 6000cGy in 25 to 30 fractions.20
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. clinically-proven inflammatory breast cancer with HER2 over expression
2. HER2 over expression detected by IHC (score 3+) or HER2 genetic over expression detected by FISH
3. clinically no distant metastasis
4. Age >=20, <=70
5. PS (ECOG) 0-1
6. written informed consent
7. adequate organ function
Key exclusion criteria
1. severe complication
2. suspicious of infection
3. past history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate
4. pregnant or lactating women
5. doctor's decision for exclusion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tabei |
Organization
Saitama Cancer Center
Division name
Endocrinology
Zip code
Address
818 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806
TEL
048-722-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name
Executive office
Zip code
Address
1550 Katayanagi, Minuma-ku, Saitama-shi, Saitama 337-0024
TEL
048-686-7155
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
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
| 2006 | Year | 11 | Month | 06 | 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
| 2005 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 03 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000621
