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The POWER Trial: Personalised Dose Optimisation With Adjuvant Tamoxifen Therapy in Breast cancER

RecruitingPhase 3Ages 18 Years - anyFemaleKarolinska Institutet
NCT07502820 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In Sweden, approximately 7000 women are diagnosed with hormone-sensitive breast cancer annually. According to international and national guidelines, most of these women are recommended anti-hormonal therapy for five to ten years to improve prognosis. Tamoxifen, one of the most widely used anti-hormonal agents globally, reduces the risk of recurrence by 40% and breast cancer mortality by 30%. Tamoxifen is a pro-drug that undergoes hepatic metabolism to form endoxifen and other active metabolites. Variability in metabolic capacity affects therapeutic efficacy: poor metabolisers produce insufficient endoxifen and other active metabolites, risking therapeutic failure, while ultrarapid metabolisers generate excessive amounts, leading to intolerable adverse effects. Today, 30-50% of patients discontinue treatment prematurely due to severe side effects, resulting in suboptimal outcomes. Curre

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with primary breast cancer, recommended for adjuvant tamoxifen treatment with or without concomitant goserelin * Premenopausal or perimenopausal, defined according to SOC for therapy decision * Eastern Cooperative Oncology Group (ECOG) WHO Performance Scale 0 - 2 * Participants must use non-hormonal contraception during the trial. Exclusion Criteria: * Previous use of tamoxifen, endoxifen, or aromatase inhibitors. * Previous medical history of: Deep venous thrombosis or pulmonary embolism; bleeding disorder or coagulopathy; macular disorders, retinal disorders, severe cataract or glaucoma. * Current use of warfarin. * Not willing to abstain from strong and moderate CYP2D6 inhibitors or CYP3A4 inducers during the tamoxifen treatment * Current pregnancy, breastfeeding, or already at start of tamoxifen planning to become pregnant within the next two years * Use of systemic menopausal hormonal therapy (MHT). * Prior invasive malignancy during the last five years. Prior or current in situ cancers are allowed.
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What it tests

  • Individual dose of tamoxifen
  • Standard adjuvant therapy of tamoxifen
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Where

4 sites
S:a Älvsborgs Sjukhus
Borås, Sweden
Skaraborgs Sjukhus
Skövde, Sweden
Capio S:t Görans Sjukhus
Stockholm, Sweden
Södersjukhuset, Onkologiska kliniken
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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