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Real-World Study on the Prognostic Impact of PIK3CA Mutations in Patients with HER2-Positive Advanced Breast Cancer

Real-World Study on the Prognostic Impact of PIK3CA Mutations in Patients with HER2-Positive Advanced Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113318
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-Positive Advanced Breast Cancer

Interventions

Patients diagnosed with HER2-positive advanced breast cancer (including locally advanced unresectable or metastatic disease):None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patients aged >=18 years; 2. Newly diagnosed with HER2-positive recurrent/metastatic breast cancer between 2019 and 2024; 3. Histopathologically confirmed invasive breast cancer (AJCC 8th edition); 4. HER2-positive status (IHC 3+ or IHC 2+ with positive FISH testing); 5. Received first-line anti-HER2 targeted therapy in the advanced setting (PH dual-targeted therapy or TKI-containing regimens); 6. Complete baseline data, treatment records, and follow-up data for at least 2 months available; 7. Tumor tissue paraffin samples accessible (from primary tumor surgery or metastatic lesion biopsy).

Exclusion criteria

Exclusion criteria: 1. Presence of other malignancies; 2. Participation in prospective/interventional clinical trials.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS);

Secondary

MeasureTime frame
Time to next treatment (TTNT);Objective response rate (ORR);Disease control rate (DCR);Progression-free survival (PFS);

Countries

China

Contacts

Public ContactWang Ouchen

The First Affiliated Hospital of Wenzhou Medical University

7505716@qq.com+86 138 1016 3244

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026