UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
Title of the study (Brief title)	Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To determine maximum tolerated dose and recommended dose of weekly nab-paclitaxel plus cyclophosphamide
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	To determine maximum tolerated dose and recommended dose
Key secondary outcomes

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	Cyclophosphamide:600 mg / m2, day1 nab-paclitaxel:80-150 mg / m2, day1,8,15 every 3 weeks
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)Histrogical confirmed inoperable and metastatic breast cancer 2)HER2 negative confirmed by IHC or FISH 3)At least one measurable lesion 4)Performance status of 0 or 1 5)Age are 20-75 years old 6)Required baseline laboratory date within 14 days WBC>=4000/mm3 Neu>=2000/mm3 Hb>=9.0g/dL Plt>=100000/mm3 T-Bill=<1.5mg/dL AST<=100IU/L ALT<=100IU/L Cr<=1.2mg/dL 7)Written informed consent
Key exclusion criteria	1)Received a taxane within 6 months in neoadjuvant or adjuvant chemotherapy before study treatment 2)Received chemotherapy for metastatic breast cancer (more than one regimen) 3)Pre-treatment paclitaxel, docetaxel, nab-paclitaxel for metastatic breast cancer 4)Received endocrine therapy within 1 week of the study treatment 5)Received irradiation within 2 weeks of the study treatment 6)Received surgery within 4 weeks of the study treatment 7)With symptomatic brain metastases 8)With grade2 or grater peripheral neuropathy, myalgia, arthralgia 9)Requiring pleural effusion, peritoneal effusion, pericardial effusion by drain 10)Undergoing (oral or intravenous) systemic continuous steroids administration 11) With serious complications (active infection, pulmonary fibrosis, diabetes, heart disease, renal failure, hepatic failure, B hepatitis, C hepatitis, HIV, etc.) 12) With a history of hypersensitivity for nab-paclitaxel, paclitaxel, albumin , cyclophosphamide and undergoing pentostatin administration, with serious bone marrow suppression, infectious diseases 13)With active double cancer 14) Pregnant or possibility of pregnant 15)Patients judged by the investigator as unfit to be enrolled in the study the study treatment
Target sample size	9

Research contact person
Name of lead principal investigator	Daisuke Ota
Organization	Mitsui Memorial Hospital
Division name	Breast Endocrine Surgery
Address	Kandaizumicho-1, Chiyoda-ku, Tokyo
TEL
Email

Public contact
Name of contact person
Organization	Mitsui Memorial Hospital
Division name	Breast Endocrine Surgery
Address
TEL	03-3862-9111
Homepage URL
Email

Sponsor
Institute	Mitsui Memorial Hospital Department of Breast Endocrine 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	2013 Year 06 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 15 Day
Anticipated trial start date	2013 Year 02 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
Other related information

Management information
Registered date	2013 Year 06 Month 12 Day
Last modified on	2016 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012740