Inavolisib-based treatment for endocrine-resistant PIK3CA-mutated HR+/HER2- advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multicenter study will collect real-world data on patients starting inavolisib for endocrine-resistant, PIK3CA‑mutated HR+/HER2‑ advanced breast cancer following recurrence on or after adjuvant endocrine therapy. PIK3CA mutation status must be confirmed by an NMPA‑approved or validated PCR or NGS assay on blood or tumor tissue before inavolisib is started. Patients may receive inavolisib as part of regimens that include palbociclib and fulvestrant according to routine clinical practice, and treatments will be recorded but not randomized. The study will gather information on safety, clinical outcomes, and treatment patterns across participating Chinese hospitals.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
  Lanzhou, Gansu, China Recruiting
• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• Wenzhou Medical University Affiliated Second Hospital
  Wenzhou, Zhejiang, China Recruiting
• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.