Brief Summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advancedat a late stage, far along or metastatic HR+/HER2- breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs following progression on or after CDK4/6 and aromatase inhibitor therapy.
Intervention / Treatment
- Drug: Gedatolisib
- Drug: Palbociclib
- Drug: Fulvestrant
- Drug: Alpelisib
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study.
- Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening until 1 year after the last dosethe amount of medication taken of study treatment
- Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncologythe study, diagnosis and treatment of cancer/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsyremoval of a section of tissue to analyse for cancer cells utilizing an assay consistent with local standards
- Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
- Adequate archival or fresh tumor tissuea group of cells that work together to perform a function for the analysis of PIK3CA mutational status
- Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints component is not allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells, hepatic, renal and coagulation function