UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
Title of the study (Brief title)	The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
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	The objective of this study is to evaluate the efficacy and safety of sequential chemotherapy with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative 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 rate Clinical complete response rate
Key secondary outcomes	Disease-free survival Overall survival Toxicity Breast conserving rate The rate of completion

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	Doxorubicin 50mg/m2, Paclitaxel 150mg/m2, q3Wx4cycles followed by paclitaxel 80mg/m2, q1Wx12cycles
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. Histologically-proven breast cancer except for inflammatory breast cancer 2. tumor diameter confirmed >=2cm and incidence of axillary metastasis 3. previously untreated with chemotherapy 4. Age >=20, <=70 5. PS(ECOG) 0-1 6. Written informed consent 7. No operation 8. Adequate organ function
Key exclusion criteria	1. severe complication 2. suspicious of infection 3. past history of allergic reaction to cremophor EL (polyoxyethylated caster oil) or polysorbate 4. Pregnant or lactating women 5. Doctor's decision for exclusion
Target sample size	30

Research contact person
Name of lead principal investigator	Toshio Tabei
Organization	Saitama Cancer Center
Division name	Endocrinology
Address	818 Komuro Ina-machi Kitaadachi-gun, Saitama 362-0806
TEL	048-722-1111
Email

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Executive office
Address	4-261-1 Kishiki-cho, Omiya-ku, Saitama City, Saitama 330-0843
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	2006 Year 10 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2005 Year 11 Month 01 Day
Anticipated trial start date	2005 Year 11 Month 28 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	2019 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2006 Year 10 Month 27 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=R000000609