Evaluation of a [68Ga] Ga-HER2 single domain antibody PET/CT for predicting pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) in HER2-positive early breast cancer

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523286-23-00

Enrollment

Registered

2026-01-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-26

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

Conditions

Breast Cancer

Brief summary

The primary endpoint will evaluate the concordance rate between the response estimated by [⁶⁸Ga]Ga-NOTA-anti-HER2-sdAb PET-CT and the complete histological response (pCR) on the invasive component (ypT0/is ypN0).

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint will evaluate the concordance rate between the response estimated by [⁶⁸Ga]Ga-NOTA-anti-HER2-sdAb PET-CT and the complete histological response (pCR) on the invasive component (ypT0/is ypN0).	—

Countries

France

Outcome results