PREDIX HER2 - Neoadjuvant response-guided treatment of HER2 positive breast cancer. Part of a platform of translational phase II trials based on molecular subtypes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508411-23-00

Enrollment

200

Registered

2023-10-02

Start date

2014-11-12

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Primary breast cancer

Brief summary

Pathological objective response to primary medical treatment

Detailed description

Clinical/radiological objective response during neoadjuvant treatment, Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer, Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS), Safety, Quality of life, Frequency of breast-conserving surgery

Interventions

DRUGHerceptin 600 mg solution for injection in vial

DRUGKadcyla 100 mg powder for concentrate for solution for infusion.

DRUGDocetaxel Accord 20 mg/1 ml concentrate for solution for infusion

DRUGPerjeta 420 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pathological objective response to primary medical treatment	—

Secondary

Measure	Time frame
Clinical/radiological objective response during neoadjuvant treatment, Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer, Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS), Safety, Quality of life, Frequency of breast-conserving surgery	—

Measure

Time frame

—

Countries

Sweden

Outcome results

None listed

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