UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Title of the study (Brief title)	Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in inoperable and/or metastatic breast cancer patients. In the next phase, we evaluate the safety and efficacy with recommended dose for these patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	To determine maximum tolerated dose and recommended dose
Key secondary outcomes	adverse events time to progression

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	The optimal dosage of gemcitabine plus paclitaxel is decided by the dose limiting toxicity
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	histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer HER2 negative over 20 years old, under 75 years old ECOG performance status--0 or 1 All Pts are 1--after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study 2--after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study Patients who have passed the following periods from previous treatment 1--immunotherapy/endocrinetherapy 14 days from the final administration, in case of LH-RH analogue, 28 days are needed 2--chemotherapy 28 days 3--radiation therapy 28 days 4--operation 7 days
Key exclusion criteria	Prior administration of gemcitabine Pulmonary fibrosis or pneumonitis Abnormal cardiac function, myocardial infarction within 6 months Body cavity fluid which needs to treatment Active infection Severe complicated situation Severe drug allergic reaction Serious psychiatric illness After bone marrow transplantation After stem cell transplantation Symptomatic systemic brain metastasis Double chemotherapy Pregnancy, breast feeding, suspected pregnancy
Target sample size	47

Research contact person
Name of lead principal investigator	Yasuhiro Suzuki
Organization	Tokai University School of Medicine
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Address	143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL	+81-463-93-1121
Email	luke-szk@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Yasuhiro Suzuki
Organization	Tokai University School of Medicine
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Address	143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL	+81-463-93-1121
Homepage URL
Email	luke-szk@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine Division of Breast and Endocrine Surgery Department of Surgery
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	2011 Year 07 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	In 1000mg/m2 of gemcitabine dose, DLT was observed in one case of 6 patienrs. This DLT was grade 4 neutropenia. And in 1250mg/m2 of gemcitabine dose, no DLT was observed. Finaly, recomended dose will be 1250mg/m2 of gemcitabine.
Other related information

Management information
Registered date	2011 Year 07 Month 21 Day
Last modified on	2018 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005291