Safety and efficacy of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ Breast Cancer patients - GLOW

Inclusion Criteria

• -Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
• -Histological confirmation of Breast Cancer with documented ER+ receptor status
• -Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
• -Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
• -Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits