Therapeutic Drug Monitoring guided tamoxifen dosing: a feasibility study in patients with hormone positive breast cancer

Completed

• Conditions: Hormone positive breast cancer; 10006291

• Registration Number: NL-OMON52690
• Lead Sponsor: Interne Oncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 457

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

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 without TDM or start dose >20 mg OD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The percentage of patients with an adequate TDM target level (endoxifen<br /><br>blood level >=16 nmol/L) at month 6 after start of tamoxifen treatment in<br /><br>comparison with the percentage patients with an adequate TDM target level<br /><br>(endoxifen blood level >=16 nmol/L) at month 1 after start of tamoxifen<br /><br>treatment. </p><br>