Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
NCT ID: NCT01553903
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
29 participants
INTERVENTIONAL
2011-12-31
2013-05-31
Brief Summary
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Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.
The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tamoxifen,
Current hormonotherapy treatment in hormone dependent breast cancer
Tamoxifen,
Tamoxifen 20 mg/day during 5 years,
Exemestane
Current hormonotherapy treatment in hormone dependent breast cancer
Exemestane
Exemestane 25mg/day during 5 years
Anastrozole
Current hormonotherapy treatment in hormone dependent breast cancer
Anastrozole
Anastrozole 1 mg/day during 5 years,
Letrozole
Current hormonotherapy treatment in hormone dependent breast cancer
Letrozole
Letrozole 2.5 mg/day during 5 years,
Interventions
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Tamoxifen,
Tamoxifen 20 mg/day during 5 years,
Exemestane
Exemestane 25mg/day during 5 years
Anastrozole
Anastrozole 1 mg/day during 5 years,
Letrozole
Letrozole 2.5 mg/day during 5 years,
Eligibility Criteria
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Inclusion Criteria
2. Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).
4. Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
5. WHO ≤ 2.
6. Women of childbearing age must use effective contraception for the duration of the study.
7. Informed consent obtained and signed before any specific procedure in the study.
8. Patient member in a national insurance scheme.
Exclusion Criteria
2. Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
3. Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
4. Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
5. Patient unable to follow procedures, visits, examinations described in the study.
6. Pregnant women or nursing mothers can not participate in the study.
7. Patients under legal guardianship.
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Principal Investigators
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Florence DALENC, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud
Locations
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Institut Claudius REGAUD
Toulouse, , France
Countries
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Other Identifiers
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11 SEIN 09
Identifier Type: -
Identifier Source: org_study_id
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