UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Acronym	Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Scientific Title	Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Scientific Title:Acronym	Clinical Benefits of Following Therapy after Anti-HER2 Standard Therapy for HER2-positive, Unresectable and/or Metastatic Breast Cancer: a Retrospective Registry Study (KBCSG-TR 1917)
Region	Japan

Condition
Condition	HER2-positive, unresectable and/or metastatic breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the real-world efficacy and prognosis of following therapy after standard treatment with anti-HER2 antibodies for patients with HER2-positive unresectable and/or metastatic breast cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.rwPFS:Real world progression-free survival 2.TTF:Time to treatment failure 3.OS:Overall survival 4.ORR:Objective response rate 5.CBR:Clinical benefit rate
Key secondary outcomes

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	Not applicable
Gender	Female
Key inclusion criteria	1)Women over 20 years old at the start of the following therapy after T-DM1 treatment 2)Has pathologically documented HER2-positive, unresectable or metastatic breast cancer 3)Has received at least one following therapy(Anti-HER2 therapy, other targeted therapy, chemotherapy and/or endocrine therapy) after T-DM1 treatment for HER2-positive unresectable or metastatic breast cancer betweeen Jan 1st, 2014 and Dec 31st, 2018
Key exclusion criteria	1) Has received any investigational new drug or any approved drug without breast cancer indication in any clinical trial as the following therapy after T-DM1 treatment 2) Has declined to participate in this study before the database has been locked
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Nakayama
Organization	Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Division name	Department of breast and endocrine surgery
Zip code	541-8567
Address	3-1-69 Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Email	taqnakayama@hotmail.com

Public contact
Name of contact person	1st name Takahiro Middle name Last name Nakayama
Organization	NPO the Supporting Center for Clinical Research and Education
Division name	Kinki Breast Cnacer Study Group-Translational Research
Zip code	565-0871
Address	2-2 Yamadamachi, Suita, Osaka
TEL	06-6897-5037
Homepage URL
Email	taqnakayama@hotmail.com

Sponsor
Institute	Kinki Breast Cancer Study Group
Institute
Department

Funding Source
Organization	DAIICHI SANKYO CO.,LTD. Oncology medical science department
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Prefectural Hospital Organization Osaka International Cancer Institute Certified Review Board
Address	3-1-69, Otemae, Chuo-ku, Osaka
Tel	06-6945-1181
Email	rinri01@opho.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	KBCSG-TR 1917
Org. issuing International ID_1	Kinki Breast Cancer Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪大学医学部附属病院（大阪府） 地方独立行政法人大阪府立病院機構　大阪国際がんセンター（大阪府） 国立病院機構大阪医療センター（大阪府） 国立病院機構北海道がんセンター（北海道） 広島市立病院機構広島市立広島市民病院（広島県）

Other administrative information
Date of disclosure of the study information	2019 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	128
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	2019 Year 07 Month 08 Day
Date of IRB	2019 Year 07 Month 18 Day
Anticipated trial start date	2019 Year 09 Month 03 Day
Last follow-up date	2019 Year 10 Month 15 Day
Date of closure to data entry	2019 Year 11 Month 22 Day
Date trial data considered complete	2019 Year 11 Month 29 Day
Date analysis concluded	2020 Year 01 Month 31 Day

Other
Other related information	We conduct a retrospective registry study to provide valuable information about the better treatment options in the post T-DM1 settings of HER2-positive unresectable of metastatic breast cancer.

Management information
Registered date	2019 Year 10 Month 15 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043525