Recruiting NCT07347600
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inavolisib, Palbociclib, Fulvestrant.
- Who it may be relevant to
- Registry conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)
Overview
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
- Drug Inavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling. - Drug Palbociclib
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling. - Drug Fulvestrant
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Primary outcome measures
- 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)]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 28 centers
- The First Affiliated Hospital of Xiamen University — Xiamen
- Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditio — Lanzhou
- The First Hospital of Jilin University — Changchun
- Wenzhou Medical University Affiliated Second Hospital — Wenzhou
- Peking University First Hospital — Beijing
- Peking University Third Hospital — Beijing
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu
- Chongqing Cancer Hospital — Chongqing
- … and 20 more centers
Identifiers
NCT: NCT07347600 · ML46361