UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Title of the study (Brief title)	A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness and safety of weekly Paclitaxel plus Gemcitabine combination therapy in patients with advanced or metastatic Breast Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival, Overall survival, Time to treatment failure, Safety profiles

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	Paclitaxel 80mg/m2,iv, Day1/8/15 Gemcitabine 1200mg/m2,iv,Day1/8 Every28 days
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	75 years-old >=
Gender	Female
Key inclusion criteria	1)Patient who confirmed histologically HER2 negative as Metastatic breast cancer 2)ECOG PS 0-1 3)Mesurable disease as per RECIST criteria 4)Patients who don't have recieved Taxans and Gemcitabine 5)Adequate organ functions confirmed with following major examination conducted within 14 days before each patient's registration leukocyte>=3000mm3 or neutrophil>=1500mm3 hemoglobin>=9.0g/dL platelet count>=100,000/mm3 AST,ALT<=100IU/L total bilirubin=<1.5mg/dL serum creatinine<=1.5mg/dL 6)Expected survival time: more than 6 months 7)Clinically no problem with an electrocardiogram 8) Given written informed concent
Key exclusion criteria	1) Pulmonary fibrosis or pneumonia 2) body cavity fluid whichi needs to be treated 3)Symptomatic brain metastasis 4) Active double cancer 5) The diabetes that is impossible of control and high blood pressure case 6)HBs antigen positive 7)Heart diseases with the following items History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months Congestive heart failure Arrhythmia which needed to be treated 8)Apparently/possibly during pregnancy or lactation expectant 9) Serious drug allergy 10) Judged by the investigator to be unfit to be enrolled into the study
Target sample size	35

Research contact person
Name of lead principal investigator	Shinya Tokunaga
Organization	Osaka City General Hospital
Division name	Department of Medical Oncology
Address	534-0021 2-13-22,miyakojima-hondori,miyakojima-ku,Osaka
TEL	06-6929-1221
Email	s-tokunaga@med.osakacity-hp.or.jp

Public contact
Name of contact person	Norikazu Masuda
Organization	Kinki Multidisciplinary Breast Oncology Group
Division name	Executive office
Address	540-0006 2-1-14,hoenzaka,chuo-ku,Osaka
TEL	06-6942-1331
Homepage URL
Email	nmasuda@alpha.ocn.ne.jp

Sponsor
Institute	Kinki Multidisciplinary Breast Oncology Group
Institute
Department

Funding Source
Organization	Sakai Clinical Research Supporting Center(SCRSC)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JAPAN

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	2010 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 10 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2013 Year 09 Month 30 Day
Date of closure to data entry	2013 Year 12 Month 31 Day
Date trial data considered complete	2013 Year 12 Month 31 Day
Date analysis concluded	2013 Year 12 Month 31 Day

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

Management information
Registered date	2010 Year 12 Month 17 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005386