NCT07543250Not yet recruiting
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 Apr 2026
- Start date
- 16 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- xuliang
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07543250
What you commit to
- Study type: Observational
- Planned participants: 100
- From 16 May 2026 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in any interventional clinical trial at enrollment.
- Presence of another active malignancy requiring concurrent systemic therapy, or missing core data preventing outcome assessment.
Other illness
- Any condition (psychiatric, social, geographical) that would preclude adequate follow-up, as judged by the investigator.
Who the study is looking for
- Histologically or cytologically confirmed HR+/HER2- recurrent or metastatic breast cancer.
- Presence of a pathogenic PIK3CA mutation confirmed by tissue or plasma-based NGS/PCR testing.
- Availability of traceable electronic medical records, imaging, laboratory, and follow-up data at baseline.
- Initiated treatment with "Inavolisib + Endocrine Therapy" with or without a CDK4/6 inhibitor in real-world clinical practice, with complete and traceable regimen information.
- Provision of informed consent for this non-interventional study (if required by the center's ethics committee).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.