UMIN-CTR Clinical Trial

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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