Adjuvante behandeling van oestrogeenreceptor positieve (HR+) borstkanker.
Conditions
Interventions
TDM guided dosage modifications are allowed during the study period. Start dosing tamoxifen 20 mg once daily, thereafter dosing advices based on blood concentration endoxifen.
Sponsors
Erasmus Medical Center, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult women (≥ 18 years of age) who are planned to start adjuvant tamoxifen therapy. 2. WHO Performance Status ≤ 1 3. Able and willing to sign the Informed Consent Form prior to screening evaluations 4. Able and willing to undergo blood sampling for PK analysis.
Exclusion criteria
Exclusion criteria: 1. Woman who are pregnant or breast feeding; 2. Endometrial cancer (diagnosis < 3 years ago) 3. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent. 4. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair treatment compliance. 5. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of tamoxifen or puts the patient at high risk for treatment related complications. 6. 3 months tamoxifen treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prove that TDM of tamoxifen is feasible in clinical practice. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Toxicity -Dose related adverse events -Compliance -Cost effectiveness -Incidence of tamoxifen induced non-alcoholic fatty liver disease | — |
Contacts
Public ContactLouwrens Braal
Erasmus MC
Outcome results
None listed