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Evaluation of the effects of increasing tamoxifen dose on the treatment process in breast cancer patients

Evaluation of the effects of increasing tamoxifen dose based on CYP2D6 genotype on the endoxifen concentration and adverse events in breast cancer patients of Isfahan city

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015082323734N1
Enrollment
100
Registered
2015-10-12
Start date
2015-10-07
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Control group: tamoxifen, 20mg oral, once a day
Intervention 1: Intervention group 1: tamoxifen, 30mg oral, twice a day. Intervention 2: Intervention group 2: tamoxifen, 40mg oral, twice a day. Intervention 3: Control group: tamoxifen, 20mg oral, o
Treatment - Drugs
Intervention group 1: tamoxifen, 30mg oral, twice a day
Intervention group 2: tamoxifen, 40mg oral, twice a day

Sponsors

Isfahan University of Medical Siences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women were eligible if they were on tamoxifen 20 mg daily for at least 4 months; nonpregnant; had normal kidney, liver, and bone marrow function. Patients were excluded if they had a concurrent medication therapy with medications known to inhibit CYP2D6.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Endoxifen. Timepoint: After using 20mg/day tamoxifen for at least 4 month, 4 month after intervention. Method of measurement: Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS).

Secondary

MeasureTime frame
Side effects. Timepoint: Four months after intervention. Method of measurement: Questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Khalaj

Isfahan University of Medical Siences

zkhalaj@resident.mui.ac.ir; z_kh240@yahoo.com; zkh240@gmail.com+98 31 3630 8467

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026