PTC299 and Hormonal Agent for Treatment of Metastatic Breast Cancer

Inclusion Criteria

• •Major Eligibility Criteria:
• •1. Female sex.
• •2. Age ≥18 years.
• •3. Body weight 40-100 kg.
• •4. ECOG performance status of 0 or 1.
• •5. Histologically or cytologically confirmed adenocarcinoma of the breast.
• •6. Presence of metastatic disease not amenable to surgery, radiation therapy, or chemoradiotherapy with curative intent.
• •7. No active second metastatic malignancy other than breast cancer.
• •8. No unstable brain or leptomeningeal disease.
• •9. Discontinuation of other therapies (except for anastrozole, letrozole, or exemestane) for the treatment of breast cancer and resolution of any acute toxic effects of prior therapies.
• •10. Adequate bone marrow, liver, and kidney function.
• •11. No uncontrolled hypertension, major bleeding, HIV infection or recent acute cardiovascular event.
• •12. If sexually active and not postmenopausal or surgically sterile, willingness to abstain from sexual intercourse or employ an effective barrier method of contraception during the study drug administration and follow-up periods.
• •13. No pregnancy or breast-feeding.
• •14. Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
• •15. Willingness to provide informed consent. In addition to the criteria noted above, Stage 2 subjects must also have natural or induced suppression of ovarian function to post-menopausal levels and be receiving or be a candidate for hormonal therapy.