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

Phase 1

• Conditions: Hormone positive breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-005124-24-NL
• Lead Sponsor: Erasmus MC Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-16
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 400

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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 clinical trial of medicinal product
• Study Design: Not specified