Inavolisib-based treatment for endocrine-resistant PIK3CA-mutated HR+/HER2- advanced breast cancer
A Prospective 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)
This trial tests an inavolisib-based regimen in people in China who have endocrine-resistant, PIK3CA-mutated, hormone receptor–positive, HER2‑negative locally advanced or metastatic breast cancer after finishing adjuvant endocrine therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 17 sites (Lanzhou, Gansu and 16 other locations) |
| Trial ID | NCT07347600 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with hormone receptor–positive, HER2‑negative locally advanced or metastatic breast cancer who are endocrine‑resistant, have a documented PIK3CA mutation by an NMPA‑approved PCR or NGS test, and are starting inavolisib for the first time are the ideal candidates.
Not a fit: Patients without a confirmed PIK3CA mutation, with HER2‑positive or HR‑ disease, or with contraindications to inavolisib per prescribing information are unlikely to benefit from this regimen.
Why it matters
Potential benefit: If successful, this regimen could provide a targeted option that delays progression and improves outcomes for patients with PIK3CA‑mutant, endocrine‑resistant HR+/HER2‑ advanced breast cancer.
How similar studies have performed: Other PI3Kα inhibitors such as alpelisib have shown clinical benefit in PIK3CA‑mutant HR+/HER2‑ metastatic breast cancer, while inavolisib is a newer agent being explored for similar use.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lanzhou, Gansu and 16 other locations
- Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine) — Lanzhou, Gansu, China (Recruiting)
- Wenzhou Medical University Affiliated Second Hospital — Wenzhou, Zhejiang, China (Recruiting)
- Peking University First Hospital — Beijing, China (Recruiting)
- Peking University Third Hospital — Beijing, China (Recruiting)
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, China (Recruiting)
- Chongqing Cancer Hospital — Chongqing, China (Recruiting)
- Zhujiang Hospital, Southern Medical University — Guangzhou, China (Recruiting)
- Harbin Medical University Cancer Hospital — Harbin, China (Recruiting)
- Shandong Provincial Hospital — Jinan, China (Recruiting)
- Jiangxi Cancer Hospital — Nanchang, China (Recruiting)
- Jiangsu Province Hospital — Nanjing, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
- Shanxi Provincial Cancer Hospital — Taiyuan, China (Recruiting)
- Taizhou Hospital of Zhejiang Province — Taizhou, China (Recruiting)
- Weifang People's Hospital — Weifang, China (Recruiting)
- Hubei Cancer Hospital — Wuhan, China (Recruiting)
- Subei People's Hospital of Jiangsu province — Yangzhou, China (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: ML46361 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.