NeoAdjuvant PErsonalized therapy in Estrogen Receptor positive breast cancer (NAPEER) - An open label phase II trial of endocrine treatment with or without capivasertib, followed by response assessment before neoadjuvant chemotherapy with bevacizumab (if ViRP signature positive).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510093-13-00

Acronym

ESR-20-20871

Enrollment

150

Registered

2024-09-05

Start date

2022-05-11

Completion date

Unknown

Last updated

2025-11-25

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

Conditions

Patients with hormone receptor positive HER2 negative breast cancer.

Brief summary

Treatment efficacy will for the primary end-point in chemotherapy part of the study be evaluated after the end of chemotherapy treatment.

Detailed description

Treatment efficacy for the primary endpoint in endocrine therapy part of the study will be evaluated by the use of Ki67 staining and quantification in the thru-cut biopsy specimen obtained at the time of the response evaluation after 15 days of therapy (+/- 3 days).

Interventions

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGTRUQAP 160 mg film-coated tablets

DRUGTRUQAP 200 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Treatment efficacy for the primary endpoint in endocrine therapy part of the study will be evaluated by the use of Ki67 staining and quantification in the thru-cut biopsy specimen obtained at the time of the response evaluation after 15 days of therapy (+/- 3 days).	—

Primary

Measure	Time frame
Treatment efficacy will for the primary end-point in chemotherapy part of the study be evaluated after the end of chemotherapy treatment.	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026