UMIN-CTR Clinical Trial

Basic information
Public title	Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
Acronym	Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Beyond PD study)
Scientific Title	Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
Scientific Title:Acronym	Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Beyond PD study)
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	The purpose of this study is to evaluate the efficacy and safety of second Trastuzumab-containing regimen(Trastuzumab/Docetaxel combination therapy) in patients progressing on first line Trastuzumab monotherapy.
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(PFS) Overall survival(OS) adverse event(AE)

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	Chemotherapy(Trastuzumab+Docetaxel)
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	Histologically confirmed mastocarcinoma Patients progriising on first line Trastuzumab monotherapy HER2 status of primary or metastatic tumour was assessed positive Measurable or evaluable lesion ECOG performance status 0,1 or 2 Age: 20-75 years old Ample organ function Signed informed consent
Key exclusion criteria	Documented history of serious hypersensitivity reaction on the medical drugs Severe complication Fever, suspicious of infection Severe pleural fluid and pericardial effusion Symptomatic brain metastasis Active double cancer Interstitial pneumonia or pulmonary fibrosis Neuropathy Grade 2,3 or 4 edema Pregnant or lactating women Doctor's decision for exclusion
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masuda Norikazu
Organization	Osaka National Hospital
Division name	Surgery(Breast Oncology)
Zip code
Address	1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL	06-6942-1331
Email

Public contact
Name of contact person	1st name Middle name Last name Norikazu MASUDA
Organization	H/D study group on Breast Cancer
Division name	Executive Office
Zip code
Address	1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL	06-6942-1331
Homepage URL
Email

Sponsor
Institute	H/D study group on Breast Cancer
Institute
Department

Funding Source
Organization	H/D study group on Breast Cancer
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

Other administrative information
Date of disclosure of the study information	2005 Year 10 Month 15 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	2002 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date	2003 Year 02 Month 01 Day
Last follow-up date	2008 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 10 Month 15 Day
Last modified on	2010 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000332

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.