Breast CancerPhase 3BATMANNCT00122356
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
A Phase 3 study testing Alendronate sodium in people with Breast Cancer, run by Barwon Health at 8 sites in Australia.
Trial summary
The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Alendronate sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 8 sitesAustralia
- Study dates
- Sep 2005to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Box Hill Hospital
Box Hill, Victoria, 3128
Maroondah Breast Clinic
East Ringwood, Victoria, 3135
St Vincent's Health
Fitzroy, Victoria, 3065
Barwon Health
Geelong, Victoria, 3220
St John of God Healthcare
Geelong, Victoria, 3220
Sydney South West Area Health Service
Sydney, New South Wales, 2050
Tweed Hospital
Tweed Heads, New South Wales, 2485
South West Healthcare
Warrnambool, Victoria, 3280
About this study
Official 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
The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.
- Conditions
- Breast Cancer
- Being tested
- Alendronate sodium
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alendronate sodiumDrug
Also called Fosamax, Alendro, Adronat
70mg tablets, once weekly
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole and alendronate | Other | Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years. Receives: Drug: Alendronate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Measured: 5 years
Secondary outcomes (7)
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Measured: 12 monthly intervals
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
Measured: 6 months after registration and/or 6 months after commencing alendronate
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
Measured: 5 years
Evaluate the clinical fracture incidence cumulative over 5 years
Measured: 5 years
Perform an economic analysis of the cost of monitoring and intervention
Measured: 5 years
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
Measured: 5 years
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barwon Health
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Karen White, Principal investigator, Barwon Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122356
- Sponsor's protocol ID
- ALCC 04.02
- Acronym
- BATMAN
- Status last verified
- Mar 2013
- First submitted
- 20 Jul 2005
- Last updated
- 13 Mar 2013
- Results posted
- No
Publications
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PubMed 38979716
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00122356
- Acronym / sponsor ID
- BATMAN / ALCC 04.02
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Barwon HealthOther government
- Collaborators
- AstraZeneca
- Study start
- Sep 2005
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anastrozole and alendronate | Other | Drug: Alendronate sodiumPatients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronate sodiumAlso: Fosamax, Alendro, Adronat70mg tablets, once weekly | Drug | Anastrozole and alendronate |
Primary outcome
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Time frame: 5 years
7 secondary outcomes
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Time frame: 12 monthly intervals
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
Time frame: 6 months after registration and/or 6 months after commencing alendronate
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
Time frame: 5 years
Evaluate the clinical fracture incidence cumulative over 5 years
Time frame: 5 years
Perform an economic analysis of the cost of monitoring and intervention
Time frame: 5 years
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
Time frame: 5 years
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 38979716Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen White principal investigator
Barwon Health
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alendronate sodium in people with Breast Cancer, run by Barwon Health at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.