Status:
UNKNOWN
Tamoxifen Citrate in Patients With Breast Cancer
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. ...
Detailed Description
OBJECTIVES: Primary * To determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in patients with hormone-sensitive breast cancer. Secondary * To charact...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00963209
Start Date
June 1 2009
End Date
December 1 2013
Last Update
August 2 2013
Active Locations (2)
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1
Hôpitaux Universitaire de Genève
Geneva, Switzerland, 1211
2
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011