Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

Breast Cancer Clinical Trial

— BATMAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122356
• Other study ID #: ALCC 04.02
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2005
• Last updated: March 11, 2013
• Start date: September 2005
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Barwon Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Alendronate sodium
70mg tablets, once weekly

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Maroondah Breast Clinic	East Ringwood	Victoria
Australia	St Vincent's Health	Fitzroy	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	St John of God Healthcare	Geelong	Victoria
Australia	Sydney South West Area Health Service	Sydney	New South Wales
Australia	Tweed Hospital	Tweed Heads	New South Wales
Australia	South West Healthcare	Warrnambool	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Barwon Health	AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment		5 years	Yes
Secondary	Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD		12 monthly intervals	Yes
Secondary	Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD		6 months after registration and/or 6 months after commencing alendronate	No
Secondary	Evaluate the Osteoporosis Australia strategy for bone protection for this patient group		5 years	No
Secondary	Evaluate the clinical fracture incidence cumulative over 5 years		5 years	Yes
Secondary	Perform an economic analysis of the cost of monitoring and intervention		5 years	No
Secondary	Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy		5 years	No
Secondary	Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy		6 months	Yes