Status:
UNKNOWN
Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
Lead Sponsor:
University of Sheffield
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 preventi...
Detailed Description
OBJECTIVES: Primary * Compare disease-free survival of women with stage II or III breast cancer at high risk of relapse treated with neoadjuvant or adjuvant chemotherapy and/or hormonal therapy with...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072020
Start Date
August 1 2003
Last Update
August 2 2013
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