UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II study of efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Acronym	Hiroshima FEmare with Actonel Trial(H-FEAT)
Scientific Title	A randomized phase II study of efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Scientific Title:Acronym	Hiroshima FEmare with Actonel Trial(H-FEAT)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	rate of change from baseline to 12 months in lumbar spine (L1-L4) bone mineral density
Key secondary outcomes	rate of change from baseline to 6 months in lumbar spine (L1-L4) bone mineral density rate of change from baseline to 12 months in total hip bone mineral density rate of change from baseline to 12 months in bone turnover markers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	period: 12months risedronate: 17.5mg/week letrozole: 2.5mg/day
Interventions/Control_2	period: 12months letrozole: 2.5mg/day
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 with hormonereceptor-positive early invasive breast cancer Patient who completed surgery, chemotherapy and radiotherapy as primary therapy within recent 12 weeks Eligible for letrozole as adjuvant therapy T-score is greater than -2.5 in lumbar spine (L1-L4) Patient who have no fracture in lumber spine and hip Patient who is not administered any medication that alter bone mineral density Proved to be eligible for administration of risedronate after consultation of dentistry Adequate general condition ECOG PS 0-2 Provided written Informed consent
Key exclusion criteria	Metastatic breast cancer Patient who have lumber spine or hip fracture Previous history of endocrine therapy for breast cancer within recent 12 months Patient who is not suitable condition for measurement of bone mineral density Patient who is planned to undergo dentistry surgery within 6 weeks Contraindication of study drugs
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Morihito Middle name Last name Okada
Organization	Hiroshima University Hospital
Division name	Respiratory Surgery
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5869
Email	morihito@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Sasada
Organization	Hiroshima University Hospital
Division name	Breast Surgery
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5869
Homepage URL	http://home.hiroshima-u.ac.jp/genge/
Email	shsasada@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
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	Center for Integrated Medical Research, Hiroshima University
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
Tel	082-257-1752
Email	protocol@cimr.hiroshima-u.ac.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	広島大学病院（広島県）、県立広島病院（広島県）、広島総合病院（広島県）

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 07 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	2011 Year 05 Month 06 Day
Date of IRB	2011 Year 05 Month 06 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2015 Year 03 Month 01 Day
Date of closure to data entry	2015 Year 06 Month 01 Day
Date trial data considered complete	2015 Year 09 Month 01 Day
Date analysis concluded	2015 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 05 Month 07 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006147