HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

Exclusion Criteria

• •Performance status (ECOG)\>2.
• •Previous or concomitant malignancy (with the exception of adequately treated nonmalignant skin cancer and carcinoma in situ of the uterine cervix
• •Metastatic breast cancer
• •Creatinine \> 1.25 times the value of upper normal limit
• •Pregnant or lactating females
• •Clinical or radiologic evidence of bone fractures
• •Treatment with systemic cortisone therapy within 12 months prior to randomization
• •Treatment with drugs that could alter bone metabolism (calcitonin, mithramycin, gallium nitrate) within 2 weeks prior to randomization
• •Previous treatment with tamoxifen or aromatase inhibitors
• •AST and/or ALT \> 3 times the value of upper normal limit with clinical and laboratory findings that indicate a grade of hepatic insufficiency that could potentially increase the risk of assuming letrozole
• •Any concomitant conditions that would, in the Investigator's opinion, contraindicate the use of any of the drugs used in this study
• •Inability to provide informed consent
• •Inability to comply with followup
• •Patient undergoing invasive dental work at time of baseline evaluation or foreseen during the course of adjuvant therapy