Breast Cancer Clinical Trial
Official title:
Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer?
Verified date | January 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet
known whether chemotherapy and/or hormone therapy are more effective with or without
zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.
PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone
therapy together with zoledronate to see how well they work compared to chemotherapy and/or
hormone therapy alone in preventing cancer recurrence and bone metastases in women with
stage II or stage III breast cancer.
Status | Active, not recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of primary breast cancer, meeting 1 of the following staging criteria: - Stage II - Stage III - T stage = T1 - Receiving OR scheduled to receive chemotherapy and/or endocrine therapy - For patients receiving neoadjuvant therapy - Tumor > 5 cm (T3), features of locally advanced disease (T4), OR biopsy-proven lymph node involvement (N1) - Scheduled to proceed to definitive surgery and/or radical radiotherapy with curative intent within 6 months of starting neoadjuvant therapy - No more than 30 days between initiation of neoadjuvant therapy and start of study drug - For patients receiving adjuvant therapy - Must have undergone complete primary tumor resection and treatment of axillary lymph nodes* - Must have lymph node involvement - No prior neoadjuvant therapy** - No more than 60 days since prior definitive surgery NOTE: *Patients whose treatment plan includes further primary tumor resection and/or treatment of the axillary lymph nodes (e.g., clearance or radiotherapy) with curative intent after completion of chemotherapy are eligible provided the treatment is completed within 9 months of study entry NOTE: **Preoperative endocrine therapy with a duration of < 30 days is not considered prior neoadjuvant therapy - No evidence of recurrent or metastatic disease - No history of breast cancer, except ductal carcinoma in situ or lobular carcinoma in situ - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Premenopausal or postmenopausal Performance status - Karnofsky 80-100% OR - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine = 1.5 times upper limit of normal Other - Not pregnant or nursing - Fertile patients must use effective contraception - No active dental problems, including dental abscess or infection of the jaw bone (e.g., maxilla or mandible) - No prior or current diagnosis of osteonecrosis of the jaw - No other malignancy within the past 5 years (including prior contralateral breast cancer) except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No history of disease with influence on bone metabolism, including any of the following: - Paget's disease of the bone - Primary hyperparathyroidism - Osteoporosis requiring treatment or likely to require treatment within the next 6 months - No other severe physical or psychological disease that would preclude study compliance - No known hypersensitivity to bisphosphonates PRIOR CONCURRENT THERAPY: Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics - More than 4 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants) - Dental fillings, teeth scaling and polishing, or minor gingival surgery within the past 4 weeks are allowed Other - More than 1 year since prior bisphosphonates - More than 30 days since prior investigational drugs - No concurrent investigational drugs (i.e., not locally approved for any indication) |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Sheffield |
Coleman R, Thorpe H, Cameron D, et al.: Zoledronic acid is well tolerated and can be safely administered with adjuvant chemotherapy first safety data from the AZURE trial (BIG01/04). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2080, S107, 2006.
Coleman R, Woodward E, Brown J, Cameron D, Bell R, Dodwell D, Keane M, Gil M, Davies C, Burkinshaw R, Houston SJ, Grieve RJ, Barrett-Lee PJ, Thorpe H. Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a r — View Citation
Coleman RE, Marshall H, Cameron D, Dodwell D, Burkinshaw R, Keane M, Gil M, Houston SJ, Grieve RJ, Barrett-Lee PJ, Ritchie D, Pugh J, Gaunt C, Rea U, Peterson J, Davies C, Hiley V, Gregory W, Bell R; AZURE Investigators. Breast-cancer adjuvant therapy wit — View Citation
Coleman RE, Winter MC, Cameron D, Bell R, Dodwell D, Keane MM, Gil M, Ritchie D, Passos-Coelho JL, Wheatley D, Burkinshaw R, Marshall SJ, Thorpe H; AZURE (BIG01/04) Investigators. The effects of adding zoledronic acid to neoadjuvant chemotherapy on tumour — View Citation
Marshall H, Gregory W, Bell R, et al.: Adjuvant therapy with zoledronic acid (AZURE-BIG 01/04): The influence of menopausal status and age on treatment effects. [Abstract] J Clin Oncol 30 (Suppl 15): A-502, 2012.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival as assessed annually for 10 years | No | ||
Secondary | Time to bone metastases as first recurrence assessed annually for 10 years | No | ||
Secondary | Time to bone metastases per se as assessed annually for 10 years | No | ||
Secondary | Time to distant metastases as assessed annually for 10 years | No | ||
Secondary | Overall survival as assessed by final analysis at 10 years | No | ||
Secondary | Skeletal-related events prior to development of bone metastases as assessed annually for 10 years | No | ||
Secondary | Skeletal-related events following development of bone metastases as assessed annually for 10 years | No | ||
Secondary | Safety and toxicity of zoledronic acid as assessed annually for 10 years | Yes | ||
Secondary | Evaluation of the influence of prognostic factors (e.g., estrogen receptor or progesterone receptor [ER/PR] status, TNM stage, tumor grade, HER2/neu, and menopausal status) on treatment outcome | No | ||
Secondary | Analysis of tumor-specific mutations, proteomics and gene expression changes in tumor cells | No |
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