NCT07618390 Fulvestrant PIK3CA mutation/HR-positive/HER2-negative Breast Cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07618390 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07618390 is a hot trial to watch
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07618390 is notable because it evaluates Fulvestrant in a Phase 2 design sponsored by Sun Yat-Sen Memorial Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07618390 |
| Official title | A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Fulvestrant |
| Sponsor | Sun Yat-Sen Memorial Hospital |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Progression-free survival (PFS) |
| Endpoint time frame | From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative (HER2-), endocrine-resistant metastatic breast cancer (mBC). Approximately 160 patients will be enrolled at around 16 centers in China. The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period. PIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of t
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Progression-free survival (PFS) (From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months) — Progression-free survival (PFS), defined as the time from initiation of the first study treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Fulvestrant is indexed as Small molecule drug, with target ER, mechanism ERs antagonists, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Sun Yat-Sen Memorial Hospital is resolved to a normalized organization record in Guangzhou, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07618390 provides a focused lens on PIK3CA mutation/HR-positive/HER2-negative Breast Cancer development. Its value will be determined by whether Fulvestrant can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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