UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004741
Receipt number R000005386
Scientific Title A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Date of disclosure of the study information 2010/12/17
Last modified on 2018/07/13 10:22:59

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Basic information

Public title

A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer

Acronym

A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer

Scientific Title

A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer

Scientific Title:Acronym

A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effectiveness and safety of weekly Paclitaxel plus Gemcitabine combination therapy in patients with advanced or metastatic Breast Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression free survival,
Overall survival,
Time to treatment failure,
Safety profiles


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

Paclitaxel 80mg/m2,iv, Day1/8/15
Gemcitabine 1200mg/m2,iv,Day1/8
Every28 days

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)Patient who confirmed histologically HER2 negative as Metastatic breast cancer
2)ECOG PS 0-1
3)Mesurable disease as per RECIST criteria
4)Patients who don't have recieved Taxans and Gemcitabine
5)Adequate organ functions confirmed with following major examination conducted within 14 days before each patient's registration
leukocyte>=3000mm3 or neutrophil>=1500mm3
hemoglobin>=9.0g/dL
platelet count>=100,000/mm3
AST,ALT<=100IU/L
total bilirubin=<1.5mg/dL
serum creatinine<=1.5mg/dL
6)Expected survival time: more than 6 months
7)Clinically no problem with an electrocardiogram
8) Given written informed concent

Key exclusion criteria

1) Pulmonary fibrosis or pneumonia
2) body cavity fluid whichi needs to be treated
3)Symptomatic brain metastasis
4) Active double cancer
5) The diabetes that is impossible of control and high blood pressure case
6)HBs antigen positive
7)Heart diseases with the following items
History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months
Congestive heart failure
Arrhythmia which needed to be treated
8)Apparently/possibly during pregnancy or lactation expectant
9) Serious drug allergy
10) Judged by the investigator to be unfit to be enrolled into the study

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Tokunaga

Organization

Osaka City General Hospital

Division name

Department of Medical Oncology

Zip code


Address

534-0021 2-13-22,miyakojima-hondori,miyakojima-ku,Osaka

TEL

06-6929-1221

Email

s-tokunaga@med.osakacity-hp.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norikazu Masuda

Organization

Kinki Multidisciplinary Breast Oncology Group

Division name

Executive office

Zip code


Address

540-0006 2-1-14,hoenzaka,chuo-ku,Osaka

TEL

06-6942-1331

Homepage URL


Email

nmasuda@alpha.ocn.ne.jp


Sponsor or person

Institute

Kinki Multidisciplinary Breast Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Sakai Clinical Research Supporting Center(SCRSC)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2010 Year 12 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2013 Year 09 Month 30 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 17 Day

Last modified on

2018 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name