UMIN-CTR Clinical Trial

Public title

A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer

Acronym

A study of TS-1 alternate-day dosing for Breast cancer

Scientific Title

A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer

Scientific Title:Acronym

A study of TS-1 alternate-day dosing for Breast cancer

Region

Japan

Condition

Metastatic/Advanced Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of TS-1 Alternate-day dosing with Metastatic/Advanced Breast Cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Progression free survival (PFS)

Key secondary outcomes

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

Dose the TS-1 of 80mg/m2 in alternate-day.

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

Female

Key inclusion criteria

1)Histologically confirmed primary breast cancer
2)Satisfies any of the following in a diagnosis of metastatic breast cancer.
1.Inoperable for distant metastasis in an initial diagnosis.
2.The cause that recurred or progressed is distant metastasis.
3)Evaluable lesions are at least one or more.
4)Received no previous chemotherapy, or only two regimen.
5)Age >= 20 years
6)ECOG performance status of 0 or 1
7)Hormonal therapies-resistant and Satisfies any of the following.
1.ER-negative breast cancer
2.Hormonal therapies-resistant in the therapy for metastatic breast cancer.
3.A recurrence during six months after adjuvant hormonal therapies or the surgery.
8)Satisfies all of the following about precedent treatment (including the adjuvant setting).
1.Pass more than 7 days, after the hormonal therapies end.
2.Pass more than 14 days, after the radiotherapy end.
9)Results from a laboratory test meet the following
WBC >= 3,500/mm3
Neu >= 2,000/mm3
Hb >= 9.0g/dL
Plt >= 100,000/mm3
T-Bil <= 1.5mg/dL
AST <= 100 IU/L
ALT <= 100 IU/L
Cre <= 1.2mg/dL
Ccr >= 60mL/min
10)Be able to be administered orally.
11)Written informed consent.

Key exclusion criteria

1)Active double cancer.
2)Watery diarrhea.
3)Require administration of flucytosine, phenytoin, and warfarin.
4)The metastases to brain which require measures for the brain hypertension and urgent brain irradiation.
5)Extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea.
6)A lesion targeted for an evaluation is only one, and there is an enforcement history of the radiotherapy to the part.
7)Pleural effusion, ascitic fluid, pericardial effusion to need urgent treatment.
8)Severe infections being suspected.
9)Interstitial pneumonia or pulmonary fibrosis.
10)HBs antigen is positive.
11)The diabetes patients with difficult control or during treatment with insulin.
12)Serious mental disorder.
13)Pregnant woman, a nursing mother or has a hope for the pregnancy.
14)The patients who are inappropriate to the study which judged by doctors.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shoji Oura

Organization

Wakayama Medical University

Division name

Department of Thoracic and Cardiovascular Surgery

Zip code

Address

811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Wakayama Medical University

Division name

Department of Thoracic and Cardiovascular Surgery

Zip code

Address

811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan

TEL

Homepage URL

Email

Institute

Wakayama Medical University, Department of Thoracic and Cardiovascular Surgery

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

Institutions

Date of disclosure of the study information

2012

Year

09

Month

07

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

Open public recruiting

Date of protocol fixation

2012

Year

09

Month

05

Day

Date of IRB

Anticipated trial start date

2012

Year

09

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

07

Day

Last modified on

2012

Year

09

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010415