Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world

Prior treatment

• 1\. Prior or current enrollment in any interventional clinical trial for ABC/MBC.
• Patients' who had prior or current exposure to alpelisib or had prior or current exposure to any other PIK3CA inhibitor should be excluded.

Other illness

• Known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
• Participant has a history of severe cutaneous reactions like Stevens-Johnson-Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
• Participant has documented pneumonitis/interstitial lung disease which is active and requiring treatment.
• Participant reports history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis, major surgery, any relevant medical condition, gastrointestinal (GI) condition preventing absorption, Child Pugh score B or C etc.

Lab values

• Participant with type I or uncontrolled type II diabetes mellitus (HbA1c \>7, \[as per ADA/ACP guidelines 2020\]).

Other

• PART A:
• Part
• PART B:
• Participant with unresolved osteonecrosis of the jaw.

• PART A:
• Males (≥18 years of age), post-menopausal\* females or pre-menopausal\*\* females with ovarian ablation (as per physician decision).
• Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic)
• Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry \[IHC\], for borderline2+ Fluorescence In Situ Hybridization \[FISH\])
• A separate signed patient ICF for Part A of the study must be obtained prior to any data collection and sample shipment to the central designated laboratory
• Patient's tumor tissue (archival or fresh) is available to be sent to a central laboratory for PIK3CA testing. In case, tissue sample (archival or fresh) is not available or feasible, liquid biopsy may be allowed.
  • PART B:
• Males (≥18 years of age), post-menopausal\* females or pre-menopausal\*\* females with ovarian ablation (as per physician decision).
• Patients with confirmed diagnosis of ABC/MBC (locoregionally recurrent not amenable to curative therapy or metastatic) - for direct enrollment patients into Part B of the study.
• Patient with histologically and/or cytologically confirmed diagnosis of HR-positive (ER+ and/or PgR+), as well as HER2-negative breast cancer by local laboratory (HER2- by Immunohistochemistry \[IHC\], for borderline2+ Fluorescence In Situ Hybridization \[FISH\]) - for direct enrollment patients into Part B of the study.
• Participants with confirmed positive PIK3CA mutation status prior to study entry.
• A separate signed ICF for Part B of the study must be obtained by all the patients, prior to any data collection, irrespective of patients who are being enrolled from Part A of the study or who are being enrolled directly into Part B of the study.
• Physician decision to treat patients with alpelisib plus fulvestrant, according to the prescribing label and the local practicing guidelines.
• Patient should be alpelisib treatment naïve.