Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a two stage study, with an initial dose escalation phase I study and subsequent
double blind randomised phase II controlled trial. Eligible patients are post-menopausal
women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should
be suitable for endocrine treatment, but have received no more than 3 previous lines of
endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also
have had progressive disease during treatment with an aromatase inhibitor. Following the
dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either
placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once
daily.
Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease
progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even
after the last trial visit.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Velindre NHS Trust Wales Cancer Trials Unit
Collaborators:
AstraZeneca Cardiff and Vale University Health Board Cenduit LLC Covance Velindre NHS Trust