Influence of Zoledronic acid (Zometa®) on bone mineral density and bone ultrasonometry in premenopausal women with hormone receptor positive breast cancer and neoadjuvant or adjuvant chemoendocrine or endocrine treatment - ProBONE II

Conditions: Hormonreceptor positive breast cancer in premenopausal women

Registration Number: EUCTR2004-002832-24-DE

Lead Sponsor: ovartis Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

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)
•Patients under adjuvant chemoendocrine or endocrine therapy: Node negative (pN-) and Node positive (pN+; <= 4 positive lymph nodes) patients
•Patients under neoadjuvant chemotherapy: no clinical evidence for nodal involvement
•Hormone receptor status (ER and/or PgR) is positive (defined as >=10% receptor positive cells or >=10fmol receptor protein/mg cytosol protein or IRS >2)
•Age >= 18 years
•Patient is premenopausal: determined by spontaneous and regular menses at diagnosis of breast cancer or by premenopausal estradiol levels (>20ng/L) at diagnosis of breast cancer
•Patient receives neoadjuvant chemotherapy or adjuvant standard chemoendocrine or endocrine therapy
•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
•Previous or concomitant malignancy (not breast cancer) within the past 5 years except adequaetely treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease-free for five years
•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