NCT07679269 Trastuzumab PIK3CA-related overgrowth syndrome Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07679269 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: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07679269 is a hot trial to watch
PIK3CA-related overgrowth syndrome is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07679269 is notable because it evaluates Trastuzumab in a Phase 2 design sponsored by Novartis Pharmaceuticals Canada, Inc.. 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 | NCT07679269 |
| Official title | Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety. (EPIK-RO) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Trastuzumab |
| Sponsor | Novartis Pharmaceuticals Canada, Inc. |
| Geography | Not reported in the indexed record |
| Enrollment | 51 |
| Primary endpoint | Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| Endpoint time frame | From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months |
| Primary completion / readout proxy | 2031-06-27 |
Protocol design and endpoint interpretation
The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 51 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.
- Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months) — Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 4.03.
Readout outlook and evidence gap
The current protocol points to 2031-06-27 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
Trial-sourced asset: Trastuzumab. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: Novartis Pharmaceuticals Canada, Inc.. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
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
NCT07679269 provides a focused lens on PIK3CA-related overgrowth syndrome development. Its value will be determined by whether Trastuzumab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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