A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

Exclusion Criteria

• •History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence.
• •Disease burden making the patient ineligible for endocrine therapy per the investigator judgement.
• •Unresolved toxicities from prior therapy greater than CTCAE grade 1.
• •Leptomeningeal metastases or symptomatic, unstable, or steroid-dependent brain metastases.
• •HbA1c ≥8.0% (63.9 mmol/mol).
• •Inadequate bone marrow reserve or organ function.
• •Severe or uncontrolled systemic diseases, uncontrolled hypertension, active infections including hepatitis B, hepatitis C, HIV, and confirmed COVID-19.
• •Known abnormalities in coagulation.
• •Refractory nausea, vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow formulated product, or significant bowel resection.
• •Previous allogenic bone marrow or solid organ transplant.
• •Known immunodeficiency syndrome.
• •Unknown or non-altered PIK3CA/AKT1/PTEN-status.
• •Evidence of dementia altered mental status or any psychiatric condition.
• •Pregnant women.
• •Participants with significant QT interval prolongation or a history of related cardiac conditions, including arrhythmias or recent cardiac procedures.
• •Prior/concomitant therapy:
• •More than 2 lines of endocrine therapy or in combination with CDK4/6i for inoperable locally advanced or metastatic disease.
• •More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for ABC.
• •AKT1, PIK3CA and mTOR inhibitors not allowed.
• •Adequate washout or dose reduction may be required for some CYP3A.
• •Participation in another clinical study with a study intervention.