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Defined as whether PIK3CA mutation is detected (positive or negative) after the enrollment of patient in Part A of the study. The mutation status should specify each 11 hotspots (C420R, E542K, E545A,E545D, E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y)
CBR defined as the proportion of patients with a best overall response of CR (complete response) or PR (partial disease), or an overall lesion response of stable disease (SD) or non-CR/non-PD (progressive disease) which lasts for a minimum time duration (with a default of at least 24 weeks in breast cancer studies). This should be evaluated as per RECIST v1.1. This endpoint measures signs of activity considering duration of disease stabilization
Two sub-groups will be identified based on age as <75 years and ≥75 years for patient's data collection
TNM staging will be collected
Disease free interval (DFI) is defined as the interval from the completion of therapy to the diagnosis of recurrence
At advanced / metastatic disease diagnosis number of metastasis will be collected
At advanced / metastatic disease diagnosis location of metastasis will be collected
To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, prior number of Line of Therapy (LoT) for the advanced / metastatic disease will be collected
To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, prior treatment type (hormone alone, hormone with targeted therapy (TT), chemotherapy, etc.) will be collected
To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, prior treatment sequence by Line of Therapy (LoT) will be collected
To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, reason (s) for discontinuation of prior therapy will be collected
To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, PIK3CA mutation positive patients not prescribed alpelisib will be collected by reason
Defined as the time from start of treatment with alpelisib plus fulvestrant (index date) to the date of the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
ORR is defined as the proportion of patients with best overall response of Complete Response (CR) or partial response (PR) evaluated based on local investigator's assessment according to RECIST 1.1
Calculated as the time from the date of the first documented Complete Response (CR) or partial response (PR) per RECIST version 1.1.
The laboratory assessment will be recorded at baseline and during the study observation period based on changes in Grade of laboratory abnormality.
To identify the treatment patterns of prior therapies received for ABC/MBC, as available in the patient's medical record, time to next treatment will be collected. Time to next treatment: defined as time gap between two Line of Therapy (LoT), as applicable
Receptor expression can be: * ER: Estrogen Receptor * PgR: Progesterone Receptor * HER2: Human Epidermal Growth Factor Receptor 2
Receptor expression can be: * ER: Estrogen Receptor * PgR: Progesterone Receptor * HER2: Human Epidermal Growth Factor Receptor 2