Locally Advanced Breast Cancer, Metastatic Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGInavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
DRUGPalbociclib
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
DRUGFulvestrant
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy * Participants must receive the treatment of inavolisib for the first time * PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\] by testing of blood or tumor tissue prior to the initiation of inavolisib
Exclusion criteria
* Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant * Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling * At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-world Progression-free Survival (rwPFS) | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Total Dose of Inavolisib Received | Up to approximately 36 months |
| Number of Participants With Adverse Events (AEs) | Up to approximately 36 months |
| Real-world Time to Progression (rwTTP) | 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 | Up to approximately 36 months |
| Real-world Duration of Response (rwDoR) | 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) | 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) | From index date to new anti-cancer therapy (up to approximately 36 months) |
| Real-world Time to Chemotherapy (rwTTC) | From index date to date of chemotherapy initiation (up to approximately 36 months) |
| Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation | Up to approximately 36 months |
| Treatment Duration of Inavolisib | Up to approximately 36 months |
Countries
China
Contacts
CONTACTReference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed