Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00122356




Registration number
NCT00122356
Ethics application status
Date submitted
20/07/2005
Date registered
22/07/2005
Date last updated
13/03/2013

Titles & IDs
Public title
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Scientific title
Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm
Secondary ID [1] 0 0
ALCC 04.02
Universal Trial Number (UTN)
Trial acronym
BATMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alendronate sodium

Other: Anastrozole and alendronate - Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.


Treatment: Drugs: Alendronate sodium
70mg tablets, once weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Timepoint [1] 0 0
12 monthly intervals
Secondary outcome [2] 0 0
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
Timepoint [2] 0 0
6 months after registration and/or 6 months after commencing alendronate
Secondary outcome [3] 0 0
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Evaluate the clinical fracture incidence cumulative over 5 years
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Perform an economic analysis of the cost of monitoring and intervention
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
Timepoint [7] 0 0
6 months

Eligibility
Key inclusion criteria
* Postmenopausal
* Adequately diagnosed and treated Stage I-IIIa early breast cancer
* Oestrogen receptor and/or progesterone receptor positive breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
* Any prior tamoxifen taken for a total of 8 weeks or less
* Any prior anastrozole taken for a total of 4 weeks or less
* Anastrozole is clinically indicated to be the best adjuvant strategy
* Signed written informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinical or radiological evidence of distant spread of disease
* Prior treatment with bisphosphonates within the past 12 months
* Prior treatment with continuous systemic corticosteroids within the past 12 months
* Prior use of parathyroid hormone for more than 1 week
* Prior use of systemic sodium fluoride for > 3 months during the past 2 years
* Currently treated with any drugs known to affect the skeleton
* Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
* History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
* Delayed oesophageal emptying such as stricture or achalasia
* Hypersensitivity to alendronate or anastrozole
* Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* AST/SGOT and/or ALT/SGPT > 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency
* Fracture due to minimal trauma, demonstrated radiologically

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney South West Area Health Service - Sydney
Recruitment hospital [2] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Maroondah Breast Clinic - East Ringwood
Recruitment hospital [5] 0 0
St Vincent's Health - Fitzroy
Recruitment hospital [6] 0 0
Barwon Health - Geelong
Recruitment hospital [7] 0 0
St John of God Healthcare - Geelong
Recruitment hospital [8] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3280 - Warrnambool

Funding & Sponsors
Primary sponsor type
Government body
Name
Barwon Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karen White
Address 0 0
Barwon Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00122356