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The POWER trial: A randomised, two-armed open label phase 3 clinical trial on personalised dose optimisation with adjuvant tamoxifen therapy after breast cancer to investigate the impact on discontinuation and efficacy compared to standard of care

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522240-40-00
Enrollment
1100
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-02

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 is discontinuation of tamoxifen.

Detailed description

BESS plus (2007) scale and subscales and the POWER symptom questionnaire, Quality of life questionnaire, Concentration of circulating plasma metabolites, Invasive disease-free survival (iDSF), Distant relapse-free survival (DRFS), Breast cancer specific survival (BCSS), Overall survival (OS), Mammographic breast density, Cost effectiveness and use of health care resources, Genetic polymorphisms in germline DNA, Biomarkers used for therapeutic drug monitoring

Interventions

DRUGTamoxifen Viatris 20 mg tabletter.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint is discontinuation of tamoxifen.

Secondary

MeasureTime frame
BESS plus (2007) scale and subscales and the POWER symptom questionnaire, Quality of life questionnaire, Concentration of circulating plasma metabolites, Invasive disease-free survival (iDSF), Distant relapse-free survival (DRFS), Breast cancer specific survival (BCSS), Overall survival (OS), Mammographic breast density, Cost effectiveness and use of health care resources, Genetic polymorphisms in germline DNA, Biomarkers used for therapeutic drug monitoring

Countries

Sweden

Outcome results

None listed

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