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

Plain-language summary

This study evaluates the effectiveness and safety of the drug Inavolisib in participants with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. Inavolisib is used together with Palbociclib and Fulvestrant, and the study can enroll patients whose PIK3CA mutation has been confirmed by an approved test and who have not previously received Inavolisib. It is a study with no assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hoffmann-La Roche

Intervention

Inavolisib, Palbociclib, Fulvestrant

Start date

1/21/2026

Estimated completion

9/9/2029

Countries

China

Related genes

Locations

• Xiamen, China
• Lanzhou, China
• Changchun, China
• Wenzhou, China
• Beijing, China
• Beijing, China
• Chengdu, China
• Chongqing, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guiyang, China
• Haikou, China
• Harbin, China
• Hefei, China
• Jinan, China
• Luoyang, China
• Nanchang, China
• Nanjing, China
• Shanghai, China
• Shanghai, China
• Shenyang, China
• Taiyuan, China
• Taizhou, China
• Weifang, China
• Wuhan, China
• Xi'an, China
• Yangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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