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To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
NCT07368998 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Inavolisib
Study Locations (14)
Other
- Cliniques Universitaires St-Luc — Brussels
- UZ Leuven Gasthuisberg — Leuven
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona — Barcelona
- Hospital Universitario San Cecilio — Granada
- Hospital Universitario 12 De Octubre — Madrid
- Hospital Clinico Universitario de Valencia — Valencia
- Adana Baskent University Hospital — Adana
- Memorial Ankara Hastanesi — Ankara
- Medical Park Seyhan Hospital — Seyhan
- Princess Alexandra Hospital — Harlow
- Mount Vernon Cancer Centre — Northwood, Middlesex
California
- Los Angeles Cancer Network — Los Angeles
New Jersey
- Astera Cancer Care East Brunswick — East Brunswick
Istanbul
- Bagcilar Medipol Mega Universitesi Hastanesi — Bağcılar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-02-18 |
| Est. Completion | 2031-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07368998
The ClinicalTrials.gov registry entry for NCT07368998 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Fulvestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07368998 reports 14 study locations spanning 4 distinct geographic areas — top geographies include Other, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07368998 about?
NCT07368998 is a clinical study titled "To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer". The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cy...
What is the current status of trial NCT07368998?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-02-18. Estimated completion is 2031-10-31.
What conditions does trial NCT07368998 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07368998?
The interventions under investigation include: Fulvestrant (DRUG), Inavolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07368998?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07368998 being conducted?
This trial has 14 study locations across California, New Jersey, Istanbul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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