UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008848
Receipt number R000005165
Scientific Title Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Date of disclosure of the study information 2012/09/04
Last modified on 2019/03/12 01:32:18

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Basic information

Public title

Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer

Acronym

Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance

Scientific Title

Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer

Scientific Title:Acronym

Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance

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 maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in Her2 negative Recurrent breast cancer patients. In the next phase, we evaluate the safety and efficacy with recommended dose for these patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To determine maximum tolerated dose and recommended dose

Key secondary outcomes

adverse events
time to progression


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

The optimal dosage of gemcitabine plus paclitaxel is decided by the dose limiting toxicity

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 or cytologically confirmed locally advanced breast cancer or metastatic breast cancer
2.HER2 negative
3.over 20 years old, under 75 years old
4.ECOG performance status--0 or 1
5.All Pts are
1:after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study
2:after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study
6.Patients who have passed the following periods from previous treatment
1:immunotherapy/endocrinetherapy
14 days from the final administration,
in case of LH-RH analogue, 28 days are
needed
2:chemotherapy 28 days
3:radiation therapy 28 days
4:operation 7 days

Key exclusion criteria

*Her2 positive
*Prior administration of gemcitabine
*Pulmonary fibrosis or pneumonitis
*Abnormal cardiac function, myocardial infarction within 6 months
*Body cavity fluid which needs to treatment
*Active infection
*Severe complicated situation
*Severe drug allergic reaction
*Serious psychiatric illness
*After bone marrow transplantation
*After stem cell transplantation
*Symptomatic systemic brain metastasis
*Active double cancer
*Double chemotherapy
*Pregnancy, breast feeding, suspected pregnancy

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Murakami

Organization

Hiroshima City Asa Hospital

Division name

Breast Surgery

Zip code


Address

2-1-1 Kabeminami Asakita-ku Hiroshima

TEL

0828155211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Murakami

Organization

Hiroshima Breast Cancer Study Group

Division name

Hiroshima Cancer Support

Zip code


Address

1-20, Honkawa-cho, Naka-ku, Hiroshima

TEL

0825443770

Homepage URL

http://www.hiroshima-cs.jp/

Email

shigeru126@gmail.com


Sponsor or person

Institute

Hiroshima Breast Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Hiroshima Breast Cancer Study Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

Hiroshima Breast Cancer Study Group(広島県)


Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 04 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

Terminated

Date of protocol fixation

2010 Year 07 Month 15 Day

Date of IRB

2010 Year 09 Month 30 Day

Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2012 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 09 Month 04 Day

Last modified on

2019 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005165


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name