Tamoxifen Citrate in Patients With Breast Cancer

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Treatments: Citric Acid; Tamoxifen

Criteria

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