Influence of Zoledronic acid (Zometa®) on bone mineral density and bone ultrasonometry in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment - ProBONE I

• Conditions: Primary, hormonreceptor negative breast cancer in premenopausal women

• Registration Number: EUCTR2004-002831-14-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-09
• Last Update Posted: 6 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•Female patients with histologically confirmed incident invasive breast cancer (T1-4).
•No evidence of distant metastasis (M0)
•Node negative (N0) and node positive (N1-4) patients
•Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
•Hormone receptor status negative
•Age >= 18 years
•Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/mL)
•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
•Patient has given written informed consent prior to any study-specific procedure
•Patient should be available for Follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of treatment or disease affecting bone metabolism (e.g., Paget’s disease, primary hyperparathyroidism)
•Known visceral metastasis or bone metastases
•Prior treatment with bisphosphonates
•Estrogens or treatments for osteoporosis in addition to calcium and vitamin D
•Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG
•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 as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients}
[72 x serum creatinine (mg/dL)]
•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.
•Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
•Use of other investigational drugs (drugs not marketed for any indication) within 6 months before start of study and participation in other clinical study.
•Pregnancy or lactation
•Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
•Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
•History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified