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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012444
Receipt No. R000014562
Scientific Title Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment
Date of disclosure of the study information 2013/11/29
Last modified on 2013/11/29

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Basic information
Public title Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment
Acronym Observational study of Pertuzumab in patients with HER2-positive MBC with the history of Trastuzumab treatment
Scientific Title Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment
Scientific Title:Acronym Observational study of Pertuzumab in patients with HER2-positive MBC with the history of Trastuzumab treatment
Region
Japan

Condition
Condition metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to assess the efficacy and the safety of Pertuzumab in combination with Trastuzumab and Docetaxel for HER2 positive metastatic breast cancer with the history of Trastuzumab treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to strategy failure
Key secondary outcomes Overall survival
Disease free survival
Response rate
Safety

Base
Study type

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 Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 50-75 mg/m2 every 3 weeks.
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria 1. Patients recieving combination chemotherapy with Pertuzumab, Trastuzumab and Docetaxel.
2. Patients with breast cancer which is confirmed to be invasive breast cancer by histological examination.
3. Reccurent/inoperable HER2-positive breast cancer patients.
4. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
5. Patients with the history of Trastuzumab treatment
6. Patients with a performance status (ECOG) of 0, 1, or 2.
7. Left ventricular ejection fraction (LVEF) is equal or greater than 50% measured by cardiac ultrasonography.
8. Patients with adequately maintained organ and bone marrow functions.
9. Patients who provided written informed consent by themselves in principle to participate in this trial.
Key exclusion criteria 1. Male patients
2. Patients with allergy to the medicines in this protocol treatment.
3. Active infection or fever suspicious of infection.
4. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Kawajiri
Organization Osaka City University Graduate School of Medicine
Division name Department of Surgical Oncology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-3838
Email hkawajiri75@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidemi Kawajiri
Organization Osaka City University Graduate School of Medicine
Division name Department of Surgical Oncology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-3838
Homepage URL
Email hkawajiri75@yahoo.co.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 大阪市立大学医学部附属病院 乳腺内分泌外科病棟・外来(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 29 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
2013 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 12 Day
Last follow-up date
2016 Year 03 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
2013 Year 11 Month 29 Day
Last modified on
2013 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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