UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004170
Receipt number R000005007
Scientific Title Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer
Date of disclosure of the study information 2010/09/07
Last modified on 2011/06/28 12:43:27

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Basic information

Public title

Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer

Acronym

PET Imaging with Cu-64 Labeled Trastuzumab

Scientific Title

Feasibility study of PET Imaging with 64Cu-DOTA-trastuzumab in HER2 positive breast cancer

Scientific Title:Acronym

PET Imaging with Cu-64 Labeled Trastuzumab

Region

Japan


Condition

Condition

1. Patients with invasive ductal carcinoma of breast.
2. HER2 positive (IHC 3+> or FISH positive) breast cancer
3. Currently taking or about to commence treatment with trastuzumab or trastumab based chemotherapy
4. Age: >20 years, < 75 years
5. ECOG Performance Score 0 or 1.
6. Good main organ function
7. Capability to be received PET scan.
8. Signed informed consent

Classification by specialty

Hematology and clinical oncology Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The study agent is a protein called 64Cu-DOTA-trastuzumab. In this study the study agent, 64Cu-DOTA-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin TM). By giving you this micro-dose 64Cu-DOTA-trastuzumab after you have treatment with trastuzumab, we will be able to use PET scans to show us which parts of your body and tumor sited the Herceptin goes to. We will be also able to detect the localaization of HER2 positive tumor by molecular imaging. The purpose of this study was to determine a feasibility of the assay.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To find recommend dose and schedule of PET scan for molecular imaging by 64Cu-DOTA-trastuzumab.

Key secondary outcomes

Second objective: To descover the novel molecular imaging to detect HER2 positive tumor inside the body without needle biopsy.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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. Patients with invasive ductal carcinoma of breast.
2. HER2 positive (IHC 3+> or FISH positive) breast cancer
3. Currently taking or about to commence treatment with trastuzumab
4. Age: >20 years, < 75 years
5. ECOG Performance Score 0 or 1.
6. Good main organ function
7. Capability to be received PET scan.
8. Signed informed consent

Key exclusion criteria

8. 1.active concomitant malignancy 2.congestive heart failure (CHF)3.uncontrolled angina pectoris, arrhythmia
4.symptomatic infectious disease
5.severe bleeding
6.pulmonary fibrosis
7.obstructive bowel disease or severe diarrhea
8.symptomatic peripheral or cardiac effusion
9.symptomatic brain metastasis.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Tamura

Organization

National Cancer Center Hospital

Division name

Breast and Medical Oncology div.

Zip code


Address

Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kenji Tamura

Organization

National Cancer Center Hospital

Division name

Breast and Medical Oncology div.

Zip code


Address

Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Homepage URL


Email

ketamura@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

MHLW (JAPAN)/Reserach for nannchi-gan

Organization

Division

Category of Funding Organization

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

独立行政法人国立がん研究センター中央病院, 乳腺科・腫瘍内科


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 07 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

Enrolling by invitation

Date of protocol fixation

2010 Year 09 Month 07 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2013 Year 10 Month 01 Day

Date of closure to data entry

2013 Year 10 Month 01 Day

Date trial data considered complete

2013 Year 10 Month 01 Day

Date analysis concluded

2013 Year 12 Month 01 Day


Other

Other related information

To determine the regimen of 64Cu-DOTA-Trasutsuzumab


Management information

Registered date

2010 Year 09 Month 07 Day

Last modified on

2011 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name