AZURE BR 2-03 - Adjuvant Zoledronic acid in patients with high risk localised breast cancer.

Phase 3

Active, not recruiting

• Conditions: High risk, localised breast cancer; Cancer - Breast

• Registration Number: ACTRN12606000293561
• Lead Sponsor: Prof Robert Coleman, The University of Sheffield, United Kingdom

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 3300

Inclusion Criteria

Patients with Stage II/III primary breast cancer - Receiving or scheduled to receive neoadjuvant or adjuvant chemotherapy and/or endocrine therapy- Performance status Eastern Cooperative Oncology Group 0 or 1- Reliable and appropriate contraception. Patient must have given written informed consent prior to study specific procedures.

Exclusion Criteria

Metastatic or recurrent breast cancer or a history of breast cancer (excluding ductal carcinoma in situ or lobular carcinoma in situ)- History of prior cancers within the preceding five years (including previous contralateral breast cancer)- History of diseases with influence on bone metabolism such as Paget's disease of the bone, primary hypothyroidism or osteoporosis requiring treatment at the time of study entry or within 6 months- Prior treatment with bisphosphonates within the past year- Serum creatinine > 1.5 x upper limit of normal- Known hypersensitivity to bisphosphonates- Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw- Recent (within 4 weeks of study entry) or planned dental or jaw surgery (eg extractions, implants)- Pregnancy or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified