UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Title of the study (Brief title)	Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate maximum tolerated dose and recommended dose of nab-Paclitaxel and Gemcitabine for metastatic breast cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	To determinate maximum tolerated dose and recommended dose
Key secondary outcomes	Safety, Response rate

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	Gemcitabine:800-1250mg/m2 day1,8 nab-Paclitaxel:220-260mg/m2 day1 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) Histologically confirmed breast cancer 2) Inoperative metastatic or recurrent breast cancer 3) Patients with evaluable lesion 4) Age are 20-75 years old 5) Prior chemotherapy regimen for metastatic breast cancer until one 6) Adequate baseline organ and marrow function as defined below: hemoglobin: >=9.0 g/dL WBC count: >=4,000/mm3 neutrophil count: >=2,000/mm3 platelet count: >=100,000 mm3 total bilirubin: =<1.5 mg/dL AST(GOT): =<ULN x 2.5 ALT(GPT): =<ULN x 2.5 serum creatinine: =<1.5 mg/dL 7) ECOG performance status (PS) 0-1 8) Patients who have passed the following periods from previous treatment (1)Endocrinetherapy:7 days from the final administration (2)Adjuvant:6 months from the final administration (3)Chemotherapy:14 days from the final administration 9) Written informed consent
Key exclusion criteria	1) Inflammatory and bilateral breast cancer 2) HER2 positive confirmed by IHC or FISH 3) Active another cancer 4) History of hypersensitivity reaction 5) Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure 6) Neuropathy <= grade1 7) Radiation therapy for chest 8) Serious myelosuppression 9) Infection 10) Pregnant or possibility pregnancy or nursing woman 11) History of hypersensitivity for albumin 12) Physician judged improper to entry this trial
Target sample size	6

Research contact person
Name of lead principal investigator	Kazuhiko Sato
Organization	Tokyo-West Tokushukai Hospital
Division name	Breast Oncology Center
Address	3-1-1, Matsubara-cho, Akishima-city, Tokyo
TEL	042-500-4433
Email	kazsato@lake.ocn.ne.jp

Public contact
Name of contact person	Masaru Iwai
Organization	Tokyo-West Tokushukai Hospital
Division name	Department of Pharmacy
Address	3-1-1, Matsubara-cho, Akishima-city, Tokyo
TEL	042-500-4433
Homepage URL
Email	masaru.iwai@tokushukai.jp

Sponsor
Institute	Tokyo-West Tokushukai Hospital
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	東京西徳洲会病院（東京都）、湘南鎌倉総合病院（神奈川県）、羽生総合病院（埼玉県）、中部徳洲会病院（沖縄県）、大垣徳洲会病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 27 Day
Anticipated trial start date	2011 Year 08 Month 18 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 26 Day
Last modified on	2016 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011858