The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
Study Type
OBSERVATIONAL
Enrollment
500
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGReal-world Progression-free Survival (rwPFS)
Time frame: From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months)
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 36 months
Real-world Time to Progression (rwTTP)
Time frame: From index date to first occurrence of PD (up to approximately 36 months)
Number of Participants With Real-world Tumor Response (rwTR) to the Treatment
Time frame: Up to approximately 36 months
Real-world Duration of Response (rwDoR)
Time frame: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)
Real-world Time-to-treatment Discontinuation (rwTTD)
Time frame: From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months)
Real-world Time to Next Treatment (rwTTNT)
Time frame: From index date to new anti-cancer therapy (up to approximately 36 months)
Real-world Time to Chemotherapy (rwTTC)
Time frame: From index date to date of chemotherapy initiation (up to approximately 36 months)
Treatment Duration of Inavolisib
Time frame: Up to approximately 36 months
Total Dose of Inavolisib Received
Time frame: Up to approximately 36 months
Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation
Time frame: Up to approximately 36 months
Reference Study ID Number: ML46361 https://forpatients.roche.com/
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