UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase II trial of weekly-paclitaxel and oral capecitabine combination therapy for metastatic breast cancer
Title of the study (Brief title)	Phase II study of paclitaxel plus capecitabine (XP) for metastatic breast cancer
Region	Japan

Condition
Condition	metastatic 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 estimate PFS and examine the execution possibility of weekly paclitaxel/oral capecitabine combination therapy for patient with metastatic breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival (PFS)
Key secondary outcomes	adverse event overall survival (OS) Time To Progression (TTF) Response rate, PFS and OS for breast cancer with ER/PgR/HER2 negative

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	1) Paclitaxel 80mg/m2 (day 1,8 q3W) 2) Capecitabine 1650mg/m2 (day 1-14 followed by a week rest q3W)
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	Male and Female
Key inclusion criteria	1. Histologically confirmed breast carcinoma. 2. clinically distant metastasis 3. previous teatment is nothing or only 1st line chemotherapy. (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen) 4. Age>=20 5. PS(ECOG) 0-1 6. Written informed consent 7. expected survival time: more than 6 months 8. Adequate organ function
Key exclusion criteria	1. severe complication 2. The brain metastasis which possesses condition 3. Past history of allergic reaction 4. Past history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 5. which has the use history of taxane or 5' DFUR or capecitabine (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen). 6. Peripheral neuropathy >= grade 2 in prior chemotherapy 7. Pregnant or lactating women 8. Doctor's decision for exclusion
Target sample size	50

Research contact person
Name of lead principal investigator	Toshio Tabei
Organization	Saitama Cancer Center
Division name	Endocrinology
Address	818 Komuro Ina Kitaadachi, 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	1550 Katayanagi Minuma Ward Saitama City, 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)

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	2007 Year 02 Month 09 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2007 Year 01 Month 29 Day
Anticipated trial start date	2007 Year 02 Month 01 Day
Last follow-up date	2008 Year 06 Month 01 Day
Date of closure to data entry	2008 Year 06 Month 01 Day
Date trial data considered complete	2008 Year 06 Month 01 Day
Date analysis concluded	2008 Year 06 Month 01 Day

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

Management information
Registered date	2007 Year 02 Month 08 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=R000000729