UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Title of the study (Brief title)	A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Region	Japan

Condition
Condition	advanced or recurrent breast cancer patients.
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm safety of Docetaxel of 100 mg/m2 to advanced or recurrent breast cancer patients
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	safety
Key secondary outcomes	pharmacokinetics pharmacodynamics efficacy

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	Docetaxel
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients aged 20 years or older at providing informed consent (2)Patients with histopathological diagnosis of breast cancer (3)Patients with recurrent breast cancer that is inoperable, unsuitable for radiation therapy or with stage IV breast cancer, regardless of whether they have a measurable lesion (4)Patients with ECOG performance status (PS) 0-1 at screening (5)Patients with functional organs as defined by the following laboratory test values at screening Hemoglobin: 8.0 g/dL or more Neutrophil count: 1,500/mm3 or more Platelet count: 100,000/mm3 or more AST (GOT), ALT (GPT): Twice the upper limit of the sites reference range or less Total bilirubin: 1.5 mg/dL or less Blood alkaline phosphatase: 2.5 times the upper limit of the sites reference range or less Serum creatinine: 1.0 mg/dL or less (6)Patients not within 2 weeks after surgery, 4 weeks after the last dose of prior chemotherapy or hormone therapy, or 2 weeks after the last dose of prior radiation therapy (7)Patients with a life expectancy of at least 3 months (8)Patients without excessive expression of HER2. However, patients with excessive expression of HER2 can participate in the trial if anti-HER2 therapy is not indicated (9)Patients in whom all clinically significant toxicity related to the prior anti-cancer therapies (surgery, radiation therapy, anticancer drug) have resolved to CTCAE (v 4.0) grade 1 or below (10)Patients who provided written informed consent of their own to participate in this trial
Key exclusion criteria	(1)Patients with a history of hypersensitivity to Docetaxel, alcohol or any drug product containing Polysorbate 80 (2)Patients with a mental disease or patients who are incapable of participating in the trial due to psychiatric symptoms (3)Patients with any uncontrollable infection (e.g., fungi, virus, bacteria) (4)Patients with unstable or untreated metastasis in the central nervous system (5)Patients with any uncontrolled heart disease including cadiomyopathy, NYHA grade III or IV heart diseases, arrhythmia, unstable angina and myocardial infarction (6)Patients with a history of treatment with Docetaxel for advanced or recurrent breast cancer. However, patients with recurrent disease can participate if the disease recurred at least 6 months after receiving the last dose of Docetaxel in a pre- and/or post-operative adjuvant chemotherapy (7)Patients who cannot tolerate pretreatment with Dexamethasone because steroids are clinically contraindicated (8)Patients with a history of or concurrent malignant tumor (9)Patients positive for anti-human immunodeficiency virus antibody, those with active chronic type B or type C hepatitis. (10)Patients with concurrent peripheral neuropathy of CTCAE (v 4.0) grade 2 or higher (11)Women who are pregnant, possibly pregnant or are lactating (12)Premenopausal, possibly pregnant female patients or fertile male patients who do not agree to practice contraception using medically approved methods from 2 weeks before the start of administration of the investigational product to 120 days after the completion of administration of the investigational product (13)Patients who cannot continue the treatment under hospitalization for at least 15 days, beginning from the start of administration of the investigational product in the first course (14)Patients otherwise unsuitable for this clinical trial in the opinion of the investigator or subinvestigator
Target sample size	6

Research contact person
Name of lead principal investigator	Taizo Hirata, M.D., Ph.D.
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
Address	2-5-1, Shikata, Kita-ku, Okayama, 700-8558
TEL	086-235-7227
Email	tahirata@okayama-u.ac.jp

Public contact
Name of contact person	Taizo Hirata, M.D., Ph.D.
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
Address	2-5-1, Shikata, Kita-ku, Okayama, 700-8558
TEL	086-235-7227
Homepage URL
Email	tahirata@okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital Center for Innovative Clinical Medicine
Institute
Department

Funding Source
Organization	Ministry of health, labor and welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014年8月18日

Institutions
Institutions	岡山大学病院（岡山県岡山市）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 02 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 15 Day
Anticipated trial start date	2014 Year 12 Month 24 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	2014 Year 12 Month 02 Day
Last modified on	2017 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018413