Breast CancerNCT00667121
Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline
An observational study of Breast Cancer and Depression, run by Mayo Clinic at 6 sites in United States.
Trial summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may help doctors learn more about the effects of other drugs on the level of tamoxifen in the blood. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Depression, Hot Flashes
- What is being tested?
- citalopram hydrobromide, escitalopram oxalate and gabapentin
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Mar 2011to 27 May 2014
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy ≥ 16 weeks * No contraindication for venlafaxine, citalopram hydrobromide, escitalopram oxalate, gabapentin, or sertraline hydrochloride PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior and no concurrent medications that are known to inhibit the CYP2D6 system
Who may be able to join
- Prescribed tamoxifen either for the prevention or treatment of non-invasive or invasive breast cancer.
- Tamoxifen use > 4 weeks without any breaks at a dose of 20 mg/day prior to registration
- to begin medical therapy with one of the following drugs: venlafaxine, citalopram, escitalopram, sertraline or gabapentin as determined by their physician
- Agree to continue tamoxifen during the proposed minimum study period of 8 weeks
- Willing to avoid known inhibitors of the CYP2D6 system for duration of study
- Ability to provide informed consent
Show all 9Show fewer
- Willing to return to primary site of enrollment for follow-up
- Life expectancy >= 16 weeks
- Agree to provide a blood specimen at the time of pre-treatment (baseline) and at follow-up
Who cannot join
- Contraindication to the use of venlafaxine, citalopram, escitalopram, gabapentin or sertraline.
- Use of medications that are known to inhibit the CYP2D6 system within 3 weeks of registration. (see appendix II for list)
- Known to be a CYP2D6 poor metabolizer (defined as homozygous for one of the following CYP2D6 null alleles: *3, *4, *5, *6).
- Note: CYP2D6 genotyping is not required prior to enrollment; however, CYP2D6 genotyping will be performed at baseline and the treating physician will be notified of the results: all genotypic CYP2D6 PM will be replaced
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Virginia Cancer Specialists PC-Arlington
Arlington, Virginia, 22205
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Antidepressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study
RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may help doctors learn more about the effects of other drugs on the level of tamoxifen in the blood.
PURPOSE: This clinical trial is studying levels of tamoxifen in the blood of women with breast cancer and in women at high risk of breast cancer who are receiving tamoxifen together with venlafaxine, citalopram, escitalopram, gabapentin, or sertraline.
Read the detailed description
OBJECTIVES:
- To examine the changes in the plasma concentrations of the hydroxylated metabolite, 4-hydroxy tamoxifen, and endoxifen in women with known or at high risk for developing breast cancer who are receiving selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy comprising venlafaxine, citalopram hydrobromide, escitalopram oxalate, gabapentin, or sertraline hydrochloride for the treatment of hot flashes, depression, or any other medically indicated condition.
- To evaluate whether genetic variants known to affect the activity of CYP2D6, SULT1A1, and other drug metabolizing enzymes (e.g., UGT's) involved in the biotransformation of tamoxifen citrate affect the plasma concentrations of the hydroxylated metabolites, 4-hydroxy tamoxifen and endoxifen.
OUTLINE: This is a multicenter study.
Patients receive oral tamoxifen citrate and concurrent selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) therapy comprising oral venlafaxine, citalopram hydrobromide, escitalopram oxalate, sertraline hydrochloride, or gabapentin for 8-24 weeks. Treatment continues in the absence of disease progression.
Blood samples are obtained at baseline and after completion of study therapy. Samples are evaluated by pharmacokinetic analysis to determine the effects of SSRI/SNRI study drugs on plasma concentrations of tamoxifen and its metabolites. Plasma levels of tamoxifen citrate, N-desmethyl tamoxifen, 4-OH tamoxifen, and endoxifen are measured using reverse phase high performance liquid chromatography. Blood samples are also analyzed by CYP2D6 genotyping to test for CYP2D6 gene variation (i.e., *3, *4, *6, *10, *17, and *41) in genes that encode tamoxifen-metabolizing enzymes. Additional CYP2D6 alleles, including gene duplication and gene deletion (*5) are assessed.
- Being tested
- citalopram hydrobromide, escitalopram oxalate, gabapentin, sertraline hydrochloride, tamoxifen citrate
- Keywords
- psychosocial effects of cancer and its treatment, breast cancer, hot flashes, depression
- Medical subject headings
- Breast Neoplasms, Depression, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopram hydrobromideDrug
escitalopram oxalateDrug
gabapentinDrug
sertraline hydrochlorideDrug
tamoxifen citrateDrug
venlafaxineDrug
molecular genetic techniqueGenetic
high performance liquid chromatographyOther
laboratory biomarker analysisOther
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in plasma concentrations of 4-hydroxy tamoxifen and of endoxifen after ≥ 8 weeks of concurrent administration of tamoxifen citrate and a CYP2D6 inhibitor
Measured: Between 8-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study start16 Mar 2011
- Primary completion12 May 2014
- Study completion27 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew P. Goetz, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667121
- Sponsor's protocol ID
- MC0738
- Other IDs
- 07-006133, NCI-2011-00406
- Status last verified
- Aug 2024
- First submitted
- 24 Apr 2008
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antidepressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study
- ClinicalTrials.gov ID
- NCT00667121
- Acronym / sponsor ID
- MC0738
- Keywords
- psychosocial effects of cancer and its treatment, breast cancer, hot flashes, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Mar 2011 (actual)
- Primary completion
- 12 May 2014 (actual)
- Study completion
- 27 May 2014 (actual)
- First posted
- 25 Apr 2008 (estimated)
- 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.
RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may help doctors learn more about the effects of other drugs on the level of tamoxifen in the blood.
PURPOSE: This clinical trial is studying levels of tamoxifen in the blood of women with breast cancer and in women at high risk of breast cancer who are receiving tamoxifen together with venlafaxine, citalopram, escitalopram, gabapentin, or sertraline.
Detailed description
OBJECTIVES:
- To examine the changes in the plasma concentrations of the hydroxylated metabolite, 4-hydroxy tamoxifen, and endoxifen in women with known or at high risk for developing breast cancer who are receiving selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy comprising venlafaxine, citalopram hydrobromide, escitalopram oxalate, gabapentin, or sertraline hydrochloride for the treatment of hot flashes, depression, or any other medically indicated condition.
- To evaluate whether genetic variants known to affect the activity of CYP2D6, SULT1A1, and other drug metabolizing enzymes (e.g., UGT's) involved in the biotransformation of tamoxifen citrate affect the plasma concentrations of the hydroxylated metabolites, 4-hydroxy tamoxifen and endoxifen.
OUTLINE: This is a multicenter study.
Patients receive oral tamoxifen citrate and concurrent selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) therapy comprising oral venlafaxine, citalopram hydrobromide, escitalopram oxalate, sertraline hydrochloride, or gabapentin for 8-24 weeks. Treatment continues in the absence of disease progression.
Blood samples are obtained at baseline and after completion of study therapy. Samples are evaluated by pharmacokinetic analysis to determine the effects of SSRI/SNRI study drugs on plasma concentrations of tamoxifen and its metabolites. Plasma levels of tamoxifen citrate, N-desmethyl tamoxifen, 4-OH tamoxifen, and endoxifen are measured using reverse phase high performance liquid chromatography. Blood samples are also analyzed by CYP2D6 genotyping to test for CYP2D6 gene variation (i.e., *3, *4, *6, *10, *17, and *41) in genes that encode tamoxifen-metabolizing enzymes. Additional CYP2D6 alleles, including gene duplication and gene deletion (*5) are assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy ≥ 16 weeks * No contraindication for venlafaxine, citalopram hydrobromide, escitalopram oxalate, gabapentin, or sertraline hydrochloride PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior and no concurrent medications that are known to inhibit the CYP2D6 system
Key inclusion criteria (9 listed)
- Prescribed tamoxifen either for the prevention or treatment of non-invasive or invasive breast cancer.
- Tamoxifen use > 4 weeks without any breaks at a dose of 20 mg/day prior to registration
- to begin medical therapy with one of the following drugs: venlafaxine, citalopram, escitalopram, sertraline or gabapentin as determined by their physician
- Agree to continue tamoxifen during the proposed minimum study period of 8 weeks
- Willing to avoid known inhibitors of the CYP2D6 system for duration of study
Key exclusion criteria (4 listed)
- Contraindication to the use of venlafaxine, citalopram, escitalopram, gabapentin or sertraline.
- Use of medications that are known to inhibit the CYP2D6 system within 3 weeks of registration. (see appendix II for list)
- Known to be a CYP2D6 poor metabolizer (defined as homozygous for one of the following CYP2D6 null alleles: *3, *4, *5, *6).
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 |
|---|---|---|
| citalopram hydrobromide | Drug | – |
| escitalopram oxalate | Drug | – |
| gabapentin | Drug | – |
| sertraline hydrochloride | Drug | – |
| tamoxifen citrate | Drug | – |
| venlafaxine | Drug | – |
| molecular genetic technique | Genetic | – |
| high performance liquid chromatography | Other | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Percent change in plasma concentrations of 4-hydroxy tamoxifen and of endoxifen after ≥ 8 weeks of concurrent administration of tamoxifen citrate and a CYP2D6 inhibitor
Time frame: Between 8-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Matthew P. Goetz, MD study chair
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Depression, run by Mayo Clinic at 6 sites in United States.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in plasma concentrations of 4-hydroxy tamoxifen and of endoxifen after ≥ 8 weeks of concurrent administration of tamoxifen citrate and a CYP2D6 inhibitor (time frame: Between 8-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2025.