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.
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou, Gansu, China
RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGWenzhou Medical University Affiliated Second Hospital
Wenzhou, Zhejiang, China
RECRUITINGPeking University First Hospital
Beijing, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGSichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China
RECRUITINGChongqing Cancer Hospital
Chongqing, China
RECRUITINGZhujiang Hospital, Southern Medical University
Guangzhou, China
RECRUITINGGuizhou Provincial People's Hospital
Guiyang, China
RECRUITINGHainan Provincial Peoples Hospital
Haikou, China
RECRUITING...and 13 more locations
Real-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/
CONTACT
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.