UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Acronym	Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance
Scientific Title	Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Scientific Title:Acronym	Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance
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 maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in Her2 negative Recurrent 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
Trial characteristics_2
Developmental phase

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	1.histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer 2.HER2 negative 3.over 20 years old, under 75 years old 4.ECOG performance status--0 or 1 5.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 6.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	*Her2 positive *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 *Active double cancer *Double chemotherapy *Pregnancy, breast feeding, suspected pregnancy
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shigeru Murakami
Organization	Hiroshima City Asa Hospital
Division name	Breast Surgery
Zip code
Address	2-1-1 Kabeminami Asakita-ku Hiroshima
TEL	0828155211
Email

Public contact
1st name of contact person	1st name Middle name Last name Shigeru Murakami
Organization	Hiroshima Breast Cancer Study Group
Division name	Hiroshima Cancer Support
Zip code
Address	1-20, Honkawa-cho, Naka-ku, Hiroshima
TEL	0825443770
Homepage URL	http://www.hiroshima-cs.jp/
Email	shigeru126@gmail.com

Sponsor
Institute	Hiroshima Breast Cancer Study Group
Institute
Department

Funding Source
Organization	Hiroshima Breast Cancer Study Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	Hiroshima Breast Cancer Study Group（広島県）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 15 Day
Date of IRB	2010 Year 09 Month 30 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 09 Month 04 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005165