Does Adjuvant Zoledronic acid redUce REcurrence in patients with high risk localised breast cancer?

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN79831382
• Lead Sponsor: The University of Sheffield (UK)

Brief Summary

2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21394500 safety and tolerability results 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21995387 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34026478/ ten-year follow-up results (added 25/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-08-20
• Study Completion: 2006-09-30
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 3360

Inclusion Criteria

Patients with stage II or III primary breast cancer

1. Female patients with Stage II/III primary breast cancer, with T stage =T1

2. Patients should be receiving/scheduled to receive chemotherapy and/or endocrine therapy

3. Patients receiving neo-adjuvant therapy
a. Must have tumour size of >5 cm (T3), features of locally advanced disease (T4) or biopsy-proven lymph node involvement

b. Should be scheduled to proceed to definitive surgery$ and/or radical radiotherapy with curative intent within 6 months of starting neoadjuvant therapy

c. Time between commencement of neoadjuvant treatment and planned start date of study drug should be =30 days

4. Patients receiving adjuvant therapy

a. Must have undergone complete primary tumour resection and treatment of the axillary lymph nodes*, without any prior neoadjuvant therapy#

b. Must have evidence of lymph node involvement

c. Time between definitive surgery and planned start date of study drug should be =60 days

5. Performance status: Karnofsky Index =80% or Eastern Cooperative Oncology Group (ECOG) 0 and 1

6. Women of childbearing potential must be using a reliable and appropriate method of contraception

7. Age =18 years

8. Patient must have given written informed consent prior to any study-specific procedures
$Final definitive surgery is considered to include re-operation for inadequate margins or another bona fide oncological indication
*Patients whose treatment plan is to proceed to further primary tumour resection and/or treatment of the axillary lymph nodes (e.g. clearance or radiotherapy) with curative intent after completion of chemotherapy would be eligible but this must be completed within 9 months of randomisation
#Pre-operative endocrine therapy of less than 30 days would not be classed as prior neoadjuvant therapy

Exclusion Criteria

1. Metastatic or recurrent breast cancer or a history of breast cancer (aside from ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]) prior to the currently diagnosed case
2. History of prior cancers within the preceding 5 years (including previous contralateral breast cancer), aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix treated with curative intent
3. History of diseases with influence on bone metabolism, such as Paget?s disease of bone, primary hyperparathyroidism or osteoporosis requiring treatment at the time of study entry or considered likely to become necessary within the subsequent 6 months
4. Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol
5. Prior treatment with bisphosphonates within the past year
6. Serum creatinine >1.5 x Upper Limit of Normal
7. Known hypersensitivity to bisphosphonates
8. 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 (ONJ)
9. Recent (within 4 weeks of study entry) or planned dental or jaw surgery (e.g. extractions, implants). Recent dental fillings, teeth scaling and polishing or minor gingival surgery do not exclude the patient.
10. Pregnancy or breast-feeding
11. Use of other investigational drugs in the 30 days prior to study entry. (Patients may be receiving treatments within a clinical trial providing the treatment under test has a licensed indication within your country).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether zoledronic acid with chemotherapy and/or endocrine therapy is superior to chemotherapy and/or endocrine therapy alone in improving disease-free survival