TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen

Exclusion Criteria

• •1. History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
• •2. Previous history of amenorrhea \> 3 months within the last 2 years (excluding pregnancy).
• •3. Ovarian insufficiency defined as serum FSH \> 20 IU/L at the local laboratory, anytime during the menstrual cycle.
• •4. Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
• •5. Pregnant or breastfeeding patients.
• •6. Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
• •7. Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
• •8. Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
• •9. Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
• •10. Known sensitivity to any of the study medications.