Tamoxifen Citrate in Patients With Breast Cancer

NCT00963209 | Unknown Phase 3

• 3 other identifiers: CDR0000650376CHUV-CEPO-TMEU-20973
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the treatment. PURPOSE: This phase III trial is studying blood samples to see if the level of active metabolites of tamoxifen can be improved in patients with breast cancer.

Conditions

Breast Cancer

Keywords

endocrine sensitive; breast cancer; tamoxifen; genotyping; phenotyping; Pharmacokinetics; Endoxifen

Outcome Measures

Primary Outcomes (1)

• Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules

  Jan 2013

Secondary Outcomes (9)

• Patients' characteristics

  prospectively

• Tumor characteristics

  prospectively

• Cancer treatments history

  prospectively

• CYP3A4 (phenotype), and possibly other cytochromes involved in the metabolism and transport of drugs

  prospectively

• Characteristics of drug intake (date of tx initiation, current dosage and frequency, time of last intake) along with patient-reported adherence, assessed by questionnaire

  prospectively

Study Arms (1)

Tamoxifen

EXPERIMENTAL

Drug: tamoxifen citrate; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

tamoxifen citrate DRUG

Tamoxifen

laboratory biomarker analysis OTHER

Tamoxifen

pharmacological study OTHER

Tamoxifen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Hormone-sensitive breast cancer defined as \> 10% estrogen receptor and/or \> 10% progesterone receptor positivity by immunohistochemistry * Receiving treatment with tamoxifen citrate and must be eligible for exposure to higher doses PATIENT CHARACTERISTICS: * No history of deep venous thrombosis or pulmonary embolism * No history of endometrial carcinoma * No known history of vaginal bleeding, endometriosis, endometrial hyperplasia, endometrial hypertrophy, and/or polyps * Not pregnant or nursing * No contraindication to tamoxifen citrate treatment * No known allergy to midazolam or dextromethorphan PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (2)

Hôpitaux Universitaire de Genève

Geneva, 1211, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Khalil Zaman, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médecin associé

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-07

Locations

CH (2)