This Phase III study is being conducted in response to the positive results from the FAKTION study and aims to evaluate the efficacy and safety of capivasertib + fulvestrant versus placebo + fulvestrant in patients with locally advanced (inoperable) or metastaic hormone receptor positive (HR+/HER2-) breast cancer following recurrence or progression on or after third generation AI therapy in an unselected population and a molecularly defined subgroup with tumours harbouring at least one PIK3CA/AKT1/PTEN – qualifying alteration detected in tissue.
Inclusion Criteria
1.)
Newly diagnosed Acute Myeloid Leukemia with no active central nervous system involvement
2.)
No history of Acute Promyelocytic Leukemia
3.)
No uncontrolled infections requiring therapy (viral, bacterial or fungal).
Exclusion Criteria
1.)
History of allergic reaction or significant sensitivity to the study drug and or other products in the same class
2.)
Candidate for allogeneic stem cell transplantation proceeding to transplant
Study Requirements
Subjects will have the following after informed consent is obtained:
Screening visit: 1.5 hours (vitals, ecg, health questions, blood, bone marrow biopsy), 8 teaspoons of blood
Cycle 1, Days 1, 2 and 5: 1 hour (vitals, study drug and blood), 7 teaspoons of blood.
Day 1 on Cycles 2, 4, 6: 1 hour (weight, Physical exam, labs, study drug), 7 teaspoons of blood.
Day 1 on Cycles 3 and 5: 1.5 hours (Questionnaires, weight, Physical exam, blood, study drug), 8 teaspoons of blood.
Days 2 to 5 on Cycles 2 to 6: ½ hour (blood, study drug), 2 teaspoons
Day 28 on Cycles 6 and 12: 1 hour (weight, physical exam, labs, study drug), 8 teaspoons of blood
Day 1 on odd Cycles 7 to 24: 1.5 hours (Questionnaires, weight, physical exam, blood, study drug), 8 teaspoons of blood.
Day 1 on even Cycles 7 to 24: 1.0 hours (weight, physical exam, blood, study drug), 8 teaspoons of blood.
Final Visit: 1.5 hours (Questionnaires, weight, physical exam, blood, bone marrow biopsy, collect study drug), 8 teaspoons of blood.
Participation may last up to 5 years (study treatment up to 2 years).
