UMIN-CTR Clinical Trial

Basic information
Public title	Study of letrozole in postmenopausal patients with breast cancer (JBCRG M02)
Acronym	JBCRG-M02 (Study of letrozole in postmenopausal patients with breast cancer)
Scientific Title	Study of letrozole in postmenopausal patients with breast cancer (JBCRG M02)
Scientific Title:Acronym	JBCRG-M02 (Study of letrozole in postmenopausal patients with breast cancer)
Region	Japan

Condition
Condition	Postmenopausal patients with breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of letrozole in postmenopausal patients with metastatic or locally advanced breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Clinical responce rate by hormone receptor status (Allred score) and Her2 status
Key secondary outcomes	Time to progression, advertse events, expression of hormone receptor-related factors

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	Letrozole 2.5 mg/day
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Postmenopausal women Metastatic or locally advanced breast cancer Hormone receptor positive breast cancer Measureable lesion Adequate organ function PS 0-2 Written informed concent
Key exclusion criteria	Inflammatory breast cancer Lymphangitic lung metastasis Brain metastasis Diffuse liver metastasis Active double cancer Prior aromatase inhibitors within one year
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Katsumasa Middle name Last name Kuroi
Organization	Metropolitan Komagome Hospital
Division name	Surgery Dept
Zip code	113-8677
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677 Japan
TEL	03-3823-2101
Email	kurochan@dd.iij4u.or.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Fukase
Organization	Japan Breast Cancer Research Group (JBCRG)
Division name	Head office
Zip code	103-0016
Address	9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL	03-6264-8873
Homepage URL	https://www.jbcrg.jp/
Email	office@jbcrg.jp

Sponsor
Institute	Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization	Japan Breast Cancer Research Group (JBCRG)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Japan Breast Cancer Research Group (JBCRG)
Address	9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
Tel	03-6264-8873
Email	office@jbcrg.jp

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	市立堺病院（大阪府）、広島市立安佐市民病院（広島県）、八尾市立病院（大阪府）、四国がんセンター（愛媛県）、名古屋市立東市民病院（愛知県）、大阪医療センター（大阪府）、都立駒込病院（東京都）

Other administrative information
Date of disclosure of the study information	2006 Year 12 Month 27 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results	Published

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	50
Results	CR2, PR16, SD over 24 weeks 20, PD1
Results date posted	2021 Year 08 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Average age　64.6; locally advanced 3, recurrent 30, metastatic 14, unknown 3 ; Soft tissue only 16, visceral 26, bone only 5, unknown 3
Participant flow	Treatment, clinical evaluation n=50
Adverse events	Grade 3,4 2(4%)
Outcome measures	Clinical response, adverse effect
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 09 Month 25 Day
Date of IRB	2006 Year 12 Month 20 Day
Anticipated trial start date	2007 Year 02 Month 20 Day
Last follow-up date	2013 Year 09 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	2006 Year 12 Month 27 Day
Last modified on	2021 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000679