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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001104
Receipt No. R000001335
Scientific Title Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy
Date of disclosure of the study information 2008/03/29
Last modified on 2011/09/28

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Basic information
Public title Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy
Acronym Z-FAST Study_Japan
Scientific Title Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy
Scientific Title:Acronym Z-FAST Study_Japan
Region
Japan

Condition
Condition Postmenopausal Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with stage 1-3a hormone receptor-positive breast cancer who received letrozole as adjuvant therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes To compare the percent change in the lumbar spine(L1-L4)BMD, as measured by DXA, at 12 months in postmenopausal women with hormone receptor-positive breast cancer randomized to zoledronic acid upfront versus delayed start.
Key secondary outcomes 1)To compare the percent change in lumbar spine(L1-L4)BMD at two years, three years, four years and five years between the two treatment groups. 2)To compare the percent change in total hip BMD at 12 months, two years, three years, four years and five years between the two treatment groups. 3)To identify changes in serum markers of bone turnover, serum NTX and BSAP, at 12 months, two years, three years, four years and five years. 4)To compare the incidence rate of all clinical fractures at three years between the two treatment groups. 5)To compare the profile of serum lipids. 6)To compare the time to disease progression between the two treatment groups. 7)To compare the overall survival between the two treatment groups. 8)Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 All patients receive letrozole 2.5 mg orally daily for 5 years or until disease progression.
Interventions/Control_2 Patients receive zoledronic acid 4mg or an adjusted dose based on renal function IV over 15 minutes infusion every 6 months for 5 years. The Upfront group receives zoledronic acid after random assignment, whereas the delayed group receives zoledronic acid when either postbaseline lumber spine BMD decreases to YAM -2.0 SD or clinical fracture occurred.
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 1)Adequately diagnosed and treated invasive breast cancer defined as: 1.Clinical stage I,II or IIIA 2.Patients with breast cancer whose tumor were removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery 2) ER and/or PgR positive defined with immunohistochemical staining 3)Postmenopausal status defined by one of the following: 1.women >54 years with cessation of menses 2.spontaneous cessation of menses within the past 1 years, but amenorrheic in women <55 years, and according to the definition of 'postmenopausal range' for FSH and estradiol level 3.bilateral oophorectomy 4)Patients with a baseline lumbar spine BMD of YAM -2.0SD or more 5)Patients who have no lumbar spine and total hip fracture 6)ECOG Performance status of 0 to 2 7)Adequate organ function 8)The date of randomization must be within 12 weeks from completion of surgery or from completion of adjuvant chemotherapy. (Completion of chemotherapy is defined as completion of the last full course including recovery time) 9)Patients who have discontinued the following drugs known as affect to the skeleton more than 4 weeks: oral bisphosphonates, estrogen, raloxifene, calcitonin, vitamin K, activated vitamin D, ipriflavone 10)A written informed consent is obtained
Key exclusion criteria 1)Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization 2)Patients with invasive bilateral breast cancer 3)Patients who have started adjuvant endocrine therapy 4)Patients who have received any endocrine therapy within the past 12 months 5)Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months 6)Patients with the following diseases which may interfere with DXA scan: severe scoliosis, immobility, hyperosteosis or sclerotic changes at the lumbar spine, calcification of abdominal aorta, vertebral diseases 7)Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years 8)Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants) 9)Other conditions judged as inappropriate for the study by the investigator
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinzaburo Noguchi
Organization Graduate School of Medicine,
Osaka University
Division name Department of Breast and Endocrine Surgery
Zip code
Address 2-2-E10 Yamada-oka, Suita-city, Osaka 565-0871, Japan
TEL 06-6879-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shunji Takahashi
Organization Cancer Institute Hospital
Division name Division of Medical Oncology
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3570-0488
Homepage URL
Email stakahas@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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
2008 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=77433
Number of participants that the trial has enrolled
Results
The upfront and delayed groups included 94 and 95 patients, respectively. At 12M, L1-L4, L2-L4, TH BMD significantly decreased by 2.0%, 2.4%, 2.4%, respectively, in the delayed group. L1-L4 BMD was 4.9% higher in the upfront group than in the delayed group (95% CI, 3.9-5.8%; p<0.001). L2-L4 BMD was 5.6% higher (95% CI, 4.5-6.6%; p< 0.001), and TH BMD was 4.4% higher (95% CI, 3.3-5.4%; p<0.001). In the upfront group, mean serum N-telopeptide and bone-specific alkaline phosphatase concentrations decreased by 23.6% (p< 0.001) and 39.4% (p<0.001), respectively, at 12M, whereas concentrations tended to increase in the delayed group by 9.4% (p=0.26) and 10.2% (p= 0.46), respectively. In conclusion, at 12M, upfront ZA therapy prevented bone loss in postmenopausal Japanese women who were receiving adjuvant LET, confirming the Z-/ZO-FAST study results in Western countries.
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 No longer recruiting
Date of protocol fixation
2008 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2014 Year 12 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
2008 Year 03 Month 28 Day
Last modified on
2011 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001335

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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