Breast CancerPhase 2NCT05133674
Therapeutic Dose Monitoring (TDM) of Tamoxifen
A Phase 2 study testing Tamoxifen 20 mg in people with Breast Cancer and Breast Carcinoma, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma, Breast Tumors
- What is being tested?
- Tamoxifen 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 4 Apr 2022to 1 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
- Performance status ECOG 0-2.
- Ongoing daily adjuvant tamoxifen minimum of 2 months ± GnRH analogues ± RT for stage 3 breast cancer.
- Locally recurrent disease, previously treated with adjuvant tamoxifen.
- Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
- Have small, wireless computing devices, such as smartphones and tablets.
Who cannot join
- Fulfilling any of the contraindications for tamoxifen.
- Metastatic (stage IV) breast cancer.
- Included in other clinical studies receiving not approved investigational medicinal drug.
- Ongoing pregnancy or lactation.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
- Ongoing daily adjuvant tamoxifen minimum of 2 months ± gonadotropin-releasing hormone (GnRH) analogues ± radiation therapy (RT) for stage 3 breast cancer.
- Locally recurrent disease, previously treated with adjuvant tamoxifen.
- Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
- Have small, wireless computing devices, such as smartphones and tablets.
Exclusion Criteria:
- Fulfilling any of the contraindications for tamoxifen.
- Metastatic (stage IV) breast cancer.
- Included in other clinical studies receiving not approved investigational medicinal drug.
- Ongoing pregnancy or lactation.
- 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).
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumors, Cancer of Breast, Malignant Neoplasm of Breast
- Being tested
- Tamoxifen 20 mg
- Keywords
- Adjuvant Tamoxifen, Endoxifen, Patient reported outcomes, Adjuvant endocrine treatment, Selective Estrogen Receptor Modulators
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen 20 mgDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 0 | Experimental | Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen will be measured. Receives: Drug: Tamoxifen 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
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).
Measured: 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.
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).
Measured: At week 3 after inclusion for each participant.
Secondary outcomes (7)
To test the correlations of concentrations found in the capillary sample (rhelise™ kit) and the venous blood sample (gold standard).
Correlations of blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen between venous blood samples and capillary blood samples (Sensitivity and specificity).
Measured: 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.
Capillary blood test concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen were taken by the patient and the research nurse.
Measured: 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.
Measured: 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.
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.
Measured: at baseline and 3 weeks
To validate the user experience of the mBraze app.
- The interview on user acceptability and attitudes toward mBraze.
Measured: at 3 weeks.
To validate the usability of the mBraze app.
- Self-reported usability and user experience of the mBraze app measured with system usability scale (SUS).
Measured: at 3 weeks.
To determine user acceptability and attitudes toward self-testing.
- The interview on user acceptability and attitudes toward self-testing.
Measured: at 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start4 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Hedayati, Karolinska University Hospital
- Investigators
- Elham Hedayati, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133674
- Sponsor's protocol ID
- TDM of TAM
- Status last verified
- May 2022
- First submitted
- 7 Oct 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Davies C, Godwin J, Gray R, Clarke M, Cutter D, Darby S, McGale P, Pan HC, Taylor C, Wang YC, Dowsett M, Ingle J, Peto R. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011 Aug 27;378(9793):771-84. doi: 10.1016/S0140-6736(11)60993-8. Epub 2011 Jul 28.
PubMed 21802721Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23.
PubMed 26211827Eriksson M, Eklund M, Borgquist S, Hellgren R, Margolin S, Thoren L, Rosendahl A, Lang K, Tapia J, Backlund M, Discacciati A, Crippa A, Gabrielson M, Hammarstrom M, Wengstrom Y, Czene K, Hall P. Low-Dose Tamoxifen for Mammographic Density Reduction: A Randomized Controlled Trial. J Clin Oncol. 2021 Jun 10;39(17):1899-1908. doi: 10.1200/JCO.20.02598. Epub 2021 Mar 18.
PubMed 33734864He W, Fang F, Varnum C, Eriksson M, Hall P, Czene K. Predictors of Discontinuation of Adjuvant Hormone Therapy in Patients With Breast Cancer. J Clin Oncol. 2015 Jul 10;33(20):2262-9. doi: 10.1200/JCO.2014.59.3673. Epub 2015 Jun 1.
PubMed 26033800Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
PubMed 21430657Fabian CJ. Will a Low-Dose Option Improve Uptake of Tamoxifen for Breast Cancer Risk Reduction? J Clin Oncol. 2019 Jul 1;37(19):1595-1597. doi: 10.1200/JCO.19.00656. Epub 2019 May 13. No abstract available.
PubMed 31082270Smith SG, Sestak I, Forster A, Partridge A, Side L, Wolf MS, Horne R, Wardle J, Cuzick J. Factors affecting uptake and adherence to breast cancer chemoprevention: a systematic review and meta-analysis. Ann Oncol. 2016 Apr;27(4):575-90. doi: 10.1093/annonc/mdv590. Epub 2015 Dec 8.
PubMed 26646754Thoren L, Lindh JD, Ackehed G, Kringen MK, Hall P, Bergh J, Molden E, Margolin S, Eliasson E. Impairment of endoxifen formation in tamoxifen-treated premenopausal breast cancer patients carrying reduced-function CYP2D6 alleles. Br J Clin Pharmacol. 2021 Mar;87(3):1243-1252. doi: 10.1111/bcp.14500. Epub 2020 Aug 9.
PubMed 32713032Borges S, Desta Z, Li L, Skaar TC, Ward BA, Nguyen A, Jin Y, Storniolo AM, Nikoloff DM, Wu L, Hillman G, Hayes DF, Stearns V, Flockhart DA. Quantitative effect of CYP2D6 genotype and inhibitors on tamoxifen metabolism: implication for optimization of breast cancer treatment. Clin Pharmacol Ther. 2006 Jul;80(1):61-74. doi: 10.1016/j.clpt.2006.03.013.
PubMed 16815318Jin Y, Desta Z, Stearns V, Ward B, Ho H, Lee KH, Skaar T, Storniolo AM, Li L, Araba A, Blanchard R, Nguyen A, Ullmer L, Hayden J, Lemler S, Weinshilboum RM, Rae JM, Hayes DF, Flockhart DA. CYP2D6 genotype, antidepressant use, and tamoxifen metabolism during adjuvant breast cancer treatment. J Natl Cancer Inst. 2005 Jan 5;97(1):30-9. doi: 10.1093/jnci/dji005.
PubMed 15632378Ferraldeschi R, Newman WG. The Impact of CYP2D6 Genotyping on Tamoxifen Treatment. Pharmaceuticals (Basel). 2010 Apr 15;3(4):1122-1138. doi: 10.3390/ph3041122.
PubMed 27713292Cronin-Fenton DP, Damkier P. Tamoxifen and CYP2D6: A Controversy in Pharmacogenetics. Adv Pharmacol. 2018;83:65-91. doi: 10.1016/bs.apha.2018.03.001. Epub 2018 May 7.
PubMed 29801584Sanchez-Spitman AB, Swen JJ, Dezentje VO, Moes DJAR, Gelderblom H, Guchelaar HJ. Effect of CYP2C19 genotypes on tamoxifen metabolism and early-breast cancer relapse. Sci Rep. 2021 Jan 11;11(1):415. doi: 10.1038/s41598-020-79972-x.
PubMed 33432065Bergqvist J, Lundstrom S, Wengstrom Y. Patient interactive digital support for women with adjuvant endocrine therapy in order to increase compliance and quality of life. Support Care Cancer. 2021 Jan;29(1):491-497. doi: 10.1007/s00520-020-05476-z. Epub 2020 May 13.
PubMed 32405965
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05133674
- Acronym / sponsor ID
- TDM of TAM
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumors, Cancer of Breast, Malignant Neoplasm of Breast
- Keywords
- Adjuvant Tamoxifen, Endoxifen, Patient reported outcomes, Adjuvant endocrine treatment, Selective Estrogen Receptor Modulators
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
- Ongoing daily adjuvant tamoxifen minimum of 2 months ± gonadotropin-releasing hormone (GnRH) analogues ± radiation therapy (RT) for stage 3 breast cancer.
- Locally recurrent disease, previously treated with adjuvant tamoxifen.
- Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
- Have small, wireless computing devices, such as smartphones and tablets.
Exclusion Criteria:
- Fulfilling any of the contraindications for tamoxifen.
- Metastatic (stage IV) breast cancer.
- Included in other clinical studies receiving not approved investigational medicinal drug.
- Ongoing pregnancy or lactation.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0 | Experimental | Drug: Tamoxifen 20 mgBlood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen will be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
- Performance status ECOG 0-2.
- Ongoing daily adjuvant tamoxifen minimum of 2 months ± GnRH analogues ± RT for stage 3 breast cancer.
- Locally recurrent disease, previously treated with adjuvant tamoxifen.
- Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
Key exclusion criteria (5 listed)
- Fulfilling any of the contraindications for tamoxifen.
- Metastatic (stage IV) breast cancer.
- Included in other clinical studies receiving not approved investigational medicinal drug.
- Ongoing pregnancy or lactation.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifen 20 mgi) 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. | Drug | 0 |
Primary outcome
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).
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).
7 secondary outcomes
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.
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.
Symptom distresses scores measured by the patient interactive digital tool (application) mBraze.
Time frame: 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
To validate the user experience of the mBraze app.
Time frame: at 3 weeks.
To validate the usability of the mBraze app.
Time frame: at 3 weeks.
To determine user acceptability and attitudes toward self-testing.
Time frame: at 3 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 21802721Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Davies C, Godwin J, Gray R, Clarke M, Cutter D, Darby S, McGale P, Pan HC, Taylor C, Wang YC, Dowsett M, Ingle J, Peto R. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011 Aug 27;378(9793):771-84. doi: 10.1016/S0140-6736(11)60993-8. Epub 2011 Jul 28.
- Background: PubMed 26211827Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23.
- Background: PubMed 33734864Eriksson M, Eklund M, Borgquist S, Hellgren R, Margolin S, Thoren L, Rosendahl A, Lang K, Tapia J, Backlund M, Discacciati A, Crippa A, Gabrielson M, Hammarstrom M, Wengstrom Y, Czene K, Hall P. Low-Dose Tamoxifen for Mammographic Density Reduction: A Randomized Controlled Trial. J Clin Oncol. 2021 Jun 10;39(17):1899-1908. doi: 10.1200/JCO.20.02598. Epub 2021 Mar 18.
- Background: PubMed 26033800He W, Fang F, Varnum C, Eriksson M, Hall P, Czene K. Predictors of Discontinuation of Adjuvant Hormone Therapy in Patients With Breast Cancer. J Clin Oncol. 2015 Jul 10;33(20):2262-9. doi: 10.1200/JCO.2014.59.3673. Epub 2015 Jun 1.
- Background: PubMed 21430657Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
- Background: PubMed 31082270Fabian CJ. Will a Low-Dose Option Improve Uptake of Tamoxifen for Breast Cancer Risk Reduction? J Clin Oncol. 2019 Jul 1;37(19):1595-1597. doi: 10.1200/JCO.19.00656. Epub 2019 May 13. No abstract available.
- Background: PubMed 26646754Smith SG, Sestak I, Forster A, Partridge A, Side L, Wolf MS, Horne R, Wardle J, Cuzick J. Factors affecting uptake and adherence to breast cancer chemoprevention: a systematic review and meta-analysis. Ann Oncol. 2016 Apr;27(4):575-90. doi: 10.1093/annonc/mdv590. Epub 2015 Dec 8.
- Background: PubMed 32713032Thoren L, Lindh JD, Ackehed G, Kringen MK, Hall P, Bergh J, Molden E, Margolin S, Eliasson E. Impairment of endoxifen formation in tamoxifen-treated premenopausal breast cancer patients carrying reduced-function CYP2D6 alleles. Br J Clin Pharmacol. 2021 Mar;87(3):1243-1252. doi: 10.1111/bcp.14500. Epub 2020 Aug 9.
- Background: PubMed 16815318Borges S, Desta Z, Li L, Skaar TC, Ward BA, Nguyen A, Jin Y, Storniolo AM, Nikoloff DM, Wu L, Hillman G, Hayes DF, Stearns V, Flockhart DA. Quantitative effect of CYP2D6 genotype and inhibitors on tamoxifen metabolism: implication for optimization of breast cancer treatment. Clin Pharmacol Ther. 2006 Jul;80(1):61-74. doi: 10.1016/j.clpt.2006.03.013.
- Background: PubMed 15632378Jin Y, Desta Z, Stearns V, Ward B, Ho H, Lee KH, Skaar T, Storniolo AM, Li L, Araba A, Blanchard R, Nguyen A, Ullmer L, Hayden J, Lemler S, Weinshilboum RM, Rae JM, Hayes DF, Flockhart DA. CYP2D6 genotype, antidepressant use, and tamoxifen metabolism during adjuvant breast cancer treatment. J Natl Cancer Inst. 2005 Jan 5;97(1):30-9. doi: 10.1093/jnci/dji005.
- Background: PubMed 27713292Ferraldeschi R, Newman WG. The Impact of CYP2D6 Genotyping on Tamoxifen Treatment. Pharmaceuticals (Basel). 2010 Apr 15;3(4):1122-1138. doi: 10.3390/ph3041122.
- Background: PubMed 29801584Cronin-Fenton DP, Damkier P. Tamoxifen and CYP2D6: A Controversy in Pharmacogenetics. Adv Pharmacol. 2018;83:65-91. doi: 10.1016/bs.apha.2018.03.001. Epub 2018 May 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham Hedayati, MD PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen 20 mg in people with Breast Cancer and Breast Carcinoma, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133674, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.