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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

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.

ClinicalTrials.gov IDNCT07347600

PhaseNot Applicable

Enrollment500

SponsorHoffmann-La Roche

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Locally Advanced Breast Cancer, Metastatic Breast Cancer

About this study

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 outcomes

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))

Eligibility information

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

Study locations

The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361003 China
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine), Lanzhou, Gansu 730050 China
The First Hospital of Jilin University, Changchun, Jilin 130021 China
Wenzhou Medical University Affiliated Second Hospital, Wenzhou, Zhejiang 325000 China
Peking University First Hospital, Beijing, 100034 China
Peking University Third Hospital, Beijing, 100191 China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital, Chengdu, 610072 China
Chongqing Cancer Hospital, Chongqing, 400030 China
Sun Yat-sen Memorial Hospital, Guangzhou, 510120 China
Zhujiang Hospital, Southern Medical University, Guangzhou, 510280 China

Showing 10 of 30 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.