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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000513
Receipt No. 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

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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
Email

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/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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