UMIN-CTR Clinical Trial

Public title

A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.

Acronym

A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.

Scientific Title

A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.

Scientific Title:Acronym

A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.

Region

Japan

Condition

advanced or recurrent breast cancer patients.

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

safety

Key secondary outcomes

pharmacokinetics
pharmacodynamics
efficacy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Taizo Hirata, M.D., Ph.D.

Organization

Okayama University Hospital

Division name

Center for Innovative Clinical Medicine

Zip code

Address

2-5-1, Shikata, Kita-ku, Okayama, 700-8558

TEL

086-235-7227

Email

tahirata@okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Taizo Hirata, M.D., Ph.D.

Organization

Okayama University Hospital

Division name

Center for Innovative Clinical Medicine

Zip code

Address

2-5-1, Shikata, Kita-ku, Okayama, 700-8558

TEL

086-235-7227

Homepage URL

Email

tahirata@okayama-u.ac.jp

Institute

Okayama University Hospital
Center for Innovative Clinical Medicine

Institute

Department

Personal name

Organization

Ministry of health, labor and welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

岡山大学病院（岡山県岡山市）

Date of disclosure of the study information

2014

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2014

Year

07

Month

15

Day

Date of IRB

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

Other related information

Registered date

2014

Year

12

Month

02

Day

Last modified on

2017

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018413