Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment (BATMAN)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Alendronate sodium

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2050
      • Sydney South West Area Health Service
    • Tweed Heads, New South Wales, Australia, 2485
      • Tweed Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • East Ringwood, Victoria, Australia, 3135
      • Maroondah Breast Clinic
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Health
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
    • Geelong, Victoria, Australia, 3220
      • St John of God Healthcare
    • Warrnambool, Victoria, Australia, 3280
      • South West Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Anastrozole and alendronate; Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.	Drug: Alendronate sodium; 70mg tablets, once weekly; Other Names: Fosamax; Alendro; Adronat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD	12 monthly intervals
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
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group	5 years
Evaluate the clinical fracture incidence cumulative over 5 years	5 years
Perform an economic analysis of the cost of monitoring and intervention	5 years
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy	5 years
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy	6 months

Collaborators and Investigators

• Sponsor: Barwon Health
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Karen White, Barwon Health

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 20, 2005
• First Submitted That Met QC Criteria: July 20, 2005
• First Posted (Estimate): July 22, 2005

Study Record Updates

• Last Update Posted (Estimate): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: ALCC 04.02