NCT00667121

Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline

Completed Last updated 14 February 2025

What this trial tests

trial testing citalopram hydrobromide in Breast Cancer in 88 participants. Completed in 27 May 2014.

Timeline

16 March 2011

Primary endpoint
12 May 2014

27 May 2014

Quick facts

Lead sponsor	Mayo Clinic
Status	Completed
Study type	OBSERVATIONAL
Enrollment	88
Start date	16 March 2011
Primary completion	12 May 2014
Estimated completion	27 May 2014
Sites	6 locations across United States

Drugs / interventions tested

• citalopram hydrobromide — full drug profile →
• escitalopram oxalate
• gabapentin (Gabapentin) — full drug profile →
• sertraline hydrochloride
• tamoxifen citrate
• venlafaxine — full drug profile →
• molecular genetic technique
• high performance liquid chromatography
• laboratory biomarker analysis
• pharmacological study
• adjuvant therapy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Depression — all drugs for Depression →
• Hot Flashes — all drugs for Hot Flashes →
• Psychosocial Effects of Cancer and Its Treatment — all drugs for Psychosocial Effects of Cancer and Its Treatment →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 120, any sex, with Breast Cancer or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Perspective of FDA Approved Drugs With P-Glycoprotein Inhibition Activities for Potential Cancer Therapeutics.
   Lai JI, Tseng YJ, Chen MH, Huang CF, et al · · 2020 · cited 107× · PMID 33312947 · DOI 10.3389/fonc.2020.561936
2. Serotonin signalling in cancer: Emerging mechanisms and therapeutic opportunities.
   Chen L, Huang S, Wu X, He W, et al · · 2024 · cited 32× · PMID 38943041 · DOI 10.1002/ctm2.1750
3. Pharmacogenomics of breast cancer therapy: an update.
   Westbrook K, Stearns V. · · 2013 · cited 26× · PMID 23500718 · DOI 10.1016/j.pharmthera.2013.03.001
4. Systematic identification of pharmacogenomics information from clinical trials.
   Li J, Lu Z. · · 2012 · cited 20× · PMID 22546622 · DOI 10.1016/j.jbi.2012.04.005
5. Metabolic Adaptations in Cancer Progression: Optimization Strategies and Therapeutic Targets.
   Dominiak A, Chełstowska B, Nowicka G. · · 2025 · cited 5× · PMID 40723225 · DOI 10.3390/cancers17142341
6. The impact of coadministration of venlafaxine, citalopram or gabapentin on the metabolic activation of tamoxifen.
   Safgren SL, Suman VJ, Leon Ferre RA, Kosel ML, et al · · 2025 · cited 1× · PMID 40011368 · DOI 10.1007/s10549-025-07644-3
7. Understanding nerve-tumor interactions: From basic biology to therapeutic innovation.
   Sun L, Li X, Wang Y, Wang J, et al · · 2026 · PMID 41938710 · DOI 10.1016/j.gendis.2025.101955