Personalised Tamoxifen Dose to Improve Treatment in Early-Stage Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The POWER trial is a phase 3 study conducted in Sweden that will tailor tamoxifen dosing to individual metabolic profiles to optimize therapy for premenopausal and perimenopausal women with primary breast cancer. Participants receive tamoxifen at a personalized dose rather than the standard 20 mg daily, with monitoring to align drug exposure with metabolism. The study also includes standard adjuvant therapy and considers concomitant goserelin as decided by clinical care. Endpoints focus on efficacy signals and tolerability, aiming to reduce treatment interruptions due to adverse effects while maintaining anti-tumor activity. Recruitment is centered in multiple Swedish centers with Karolinska Institutet as lead sponsor and support from national cancer organizations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Skaraborgs Sjukhus
  Skövde, Sweden Recruiting
• Södersjukhuset, Onkologiska kliniken
  Stockholm, Sweden Recruiting
• S:a Älvsborgs Sjukhus
  Borås, Sweden Not yet recruiting
• Capio S:t Görans Sjukhus
  Stockholm, Sweden Not yet recruiting

Study contacts

• Principal investigator: Marike Gabrielson, PhD — Karolinska Institutet
• Study coordinator: Helena Aaröe, RN
• Email: powerstudien-meb@ki.se
• Phone: +46852482267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.