A study to investigate efficacy and safety with oral AZD9833 compared with intramuscular fulvestrant in post-menopausal women at least 18 years of age with advanced ER-positive HER2 negative breast cancer - SERENA-2

Exclusion Criteria

• Intervention with any of the following:
• • Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
• • Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to the first dose of study treatment.
• • Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4/5 and sensitive CYP2B6 substrates, and drugs which are substrates of
• CYP2C9 and/or CYP2C19 which have a narrow therapeutic index or inability to stop use within the washout period prior to receiving the first dose of study treatment.
• • Drugs that are known to prolong QT and have a known risk of torsades de pointes.
• • The following cardiovascular criteria: QTcF >470 ms, resting heart rate <45 bpm, clinically significant abnormalities of resting electrocardiogram, uncontrolled hypertension, symptomatic hypotension, factors that increase the risk for QTc prolongation, left ventricular ejection fraction <50%.
• • Radiotherapy with a limited field of radiation for palliation within 1 week of dosing, or to > 30% of bone marrow or a wide field within 4 weeks of dosing.
• • Major surgical procedure or significant traumatic injury.
• • Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system metastatic disease.
• • Inadequate bone marrow reserve or organ function.
• • Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833.
• • History of hypersensitivity to active or inactive excipients of AZD9833 or fulvestrant.
• • Previous randomisation in the present study.
• • Women of childbearing potential.