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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001205
Receipt No. R000001470
Scientific Title Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Date of disclosure of the study information 2008/06/21
Last modified on 2018/12/18

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Basic information
Public title Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Acronym Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Scientific Title Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Scientific Title:Acronym Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Region
Japan

Condition
Condition Primary breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy and the safety for the treatment of weekly paclitaxel (wPTX) followed by doxorubicin(ADM) plus paclitaxel in neo-adjuvant chemotherapy for Breast Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response; pCR rate
Key secondary outcomes Clinical response rate
Disease free survival
Overall survival
Breast conserving rate
Treatment compliance
Biomarkers

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 12 cycles of wPTX followed by 4 cycles of ADM+PTX (AP)
PTX 80mg/m2 12 cycles
1) day1; PTX 80mg/m2

after completion wPTX, day22 would be day1 and followed by AP 4 cycles
(q3weeks)
1) day1; ADM 50mg/m2
2) day1; PTX 150mg/m2
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)Histologically confirmed primary breast cancer
2)Tumor diamiter >2cm or Node positive
3) No prior chemotherapy for breast cancer
4) Age >20 y
5)ECOG PS 0-1
6)Hormone receptor negative;
ER(-) and PgR(-), less than 10% by immunohistochemistry
7)HER2 negative (<1 by HercepTest, if 2+ by HercepTest, Signal ratio <2.0 by FISH)
8) Written informed consent
9) No operation for breast cancer
10) Adequate main organ functions
Key exclusion criteria 1)Severe complication
2)Inflammatory breast caner and male breast cancer
3)Ischemic heart disease or arrhythmia which needs medical treatment (history of myocardial infarction occured within 6 months)
4)Uncontrolled diabetes
5)Suspicious of infection
6)History of serious hypersensitivity or history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate
7)During pregnancy or lactation
8)Patient judged inappropriate by physicians
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Tabei
Organization Saitama Cancer Center
Division name Breast Medical Oncology
Zip code
Address 818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan
TEL 048-722-1111
Email toshikai@sbccsg.org

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name Secretariat Division (Shintoshin Ladies' MammoClinic)
Zip code
Address 3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL 048-600-1722
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
2008 Year 06 Month 21 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 No longer recruiting
Date of protocol fixation
2008 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2019 Year 04 Month 01 Day
Date of closure to data entry
2019 Year 06 Month 01 Day
Date trial data considered complete
2019 Year 08 Month 01 Day
Date analysis concluded
2020 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 20 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001470

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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