UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Title of the study (Brief title)	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	Toshio Tabei
Organization	Saitama Cancer Center
Division name	Breast Medical Oncology
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	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' MammoClinic)
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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