Therapeutic Dose Monitoring (TDM) of Tamoxifen

May 24, 2022 updated by: Elham Hedayati, Karolinska University Hospital

Therapeutic Dose Monitoring (TDM) of Tamoxifen and Its Active Metabolites in Combination With Patient-reported Symptom Scores Among Patients With Breast Cancer Receiving Adjuvant Tamoxifen Treatment

Tamoxifen is a potent and effective drug reducing the risk of dying from breast cancer in the adjuvant setting. Although more modern drugs have partly replaced tamoxifen, it is helpful in the neoadjuvant and metastatic settings as a single drug. Despite that, in the adjuvant setting, it is a valuable drug.

This study aims to validate and study the feasibility of serial assessments, including therapeutic drug monitoring of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen by capillary blood sampling, combined with patient-reported symptom scores. This will provide preliminary data to allow us to develop a future multicentre randomised clinical trial of personalised dose monitoring and adjustment of adjuvant tamoxifen therapy to enhance the quality of life and breast cancer outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This repeated-measures, prospective, open-label, single-centre study is designed for women with stage 0-3 breast cancer receiving adjuvant tamoxifen 20 mg/day.

Inclusion criteria:

  1. Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
  2. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
  3. Ongoing daily adjuvant tamoxifen minimum of 2 months ± gonadotropin-releasing hormone (GnRH) analogues ± radiation therapy (RT) for stage 3 breast cancer.
  4. Locally recurrent disease, previously treated with adjuvant tamoxifen.
  5. Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
  6. Have small, wireless computing devices, such as smartphones and tablets.

Exclusion Criteria:

  1. Fulfilling any of the contraindications for tamoxifen.
  2. Metastatic (stage IV) breast cancer.
  3. Included in other clinical studies receiving not approved investigational medicinal drug.
  4. Ongoing pregnancy or lactation.
  5. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

No. Of Subjects: 40 female subjects.

Measured components: Tamoxifen, 4-hydroxytamoxifen and Z-endoxifen

Study design: Blood samples for measurement of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen will be drawn capillary in total at 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant; and venously in total at 2-time points, at inclusion (baseline), and after 3 weeks for each participant.

At each time, participants will be asked to leave 2 vials of capillary blood (50ul x2) using the rhelise™ kit and 2 samples of conventional venous blood for blood and plasma (5 ml x 2).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
  2. Performance status ECOG 0-2.
  3. Ongoing daily adjuvant tamoxifen minimum of 2 months ± GnRH analogues ± RT for stage 3 breast cancer.
  4. Locally recurrent disease, previously treated with adjuvant tamoxifen.
  5. Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
  6. Have small, wireless computing devices, such as smartphones and tablets.

Exclusion Criteria:

  1. Fulfilling any of the contraindications for tamoxifen.
  2. Metastatic (stage IV) breast cancer.
  3. Included in other clinical studies receiving not approved investigational medicinal drug.
  4. Ongoing pregnancy or lactation.
  5. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental
Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen will be measured.
Drug: Tamoxifen 20 mg
i) a self-testing capillary kit, the rhelise™ kit for measuring the concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen and ii) a patient interactive digital tool (app) mBraze to collect data about symptoms and guide breast cancer patients on adjuvant tamoxifen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
Time Frame: At at inclusion (baseline) for each participant.
Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen at baseline, two weeks, 1, 2, and 3 weeks by capillary and venous blood sampling (whole blood/plasma).
At at inclusion (baseline) for each participant.
To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
Time Frame: At week 3 after inclusion for each participant.
Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen at baseline, two weeks, 1, 2, and 3 weeks by capillary and venous blood sampling (whole blood/plasma).
At week 3 after inclusion for each participant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To test the correlations of concentrations found in the capillary sample (rhelise™ kit) and the venous blood sample (gold standard).
Time Frame: At 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant.
Correlations of blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen between venous blood samples and capillary blood samples (Sensitivity and specificity).
At 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant.
To validate user acceptability and feasibility of self-testing the capillary kit.
Time Frame: At 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant.
Capillary blood test concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen were taken by the patient and the research nurse.
At 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant.
Symptom distresses scores measured by the patient interactive digital tool (application) mBraze.
Time Frame: at baseline and 3 weeks.
at baseline and 3 weeks.
To compare and correlate blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen with patient-reported outcome measures and the application mBraze for symptom self-monitoring.
Time Frame: at baseline and 3 weeks

Correlations between tamoxifen, 4-hydroxytamoxifen and Z-endoxifen concentrations and symptom distress score ((fatigue, insomnia, pain, body image, and systemic therapy side-effect and cognitive-, emotional-, role-, sexual and social functioning).

Correlations between tamoxifen, 4-hydroxytamoxifen and Z-endoxifen concentrations and symptom distress in the same patient.
at baseline and 3 weeks
To validate the user experience of the mBraze app.
Time Frame: at 3 weeks.
- The interview on user acceptability and attitudes toward mBraze.
at 3 weeks.
To validate the usability of the mBraze app.
Time Frame: at 3 weeks.
- Self-reported usability and user experience of the mBraze app measured with system usability scale (SUS).
at 3 weeks.
To determine user acceptability and attitudes toward self-testing.
Time Frame: at 3 weeks.
- The interview on user acceptability and attitudes toward self-testing.
at 3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Elham Hedayati, MD PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDM of TAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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