Status:
TERMINATED
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic acti...
Eligibility Criteria
Inclusion
- Female patients with histologically confirmed incident invasive breast cancer (T1-4) with no evidence of regional lymph node metastasis (N0) or distant metastasis (M0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
- Hormone receptor status is negative
- Patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (\>10ng/dL)
- Patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. AC 4-6 cycles) (prior neoadjuvant CT is allowed)
- Bone density at study entry \> -2.5 T-Score
Exclusion
- Prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin D
- Severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
- Known hypersensitivity to bisphosphonates
- Abnormal renal function
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00333229
Start Date
March 1 2006
End Date
December 1 2013
Last Update
November 25 2014
Active Locations (1)
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1
Novartis Investigative Site
Marburg, Germany, 35043