Clinical trial NCT01553903: Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
Official title: Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Hormonal therapy
Breast Cancer
AEBS
Oxysterols
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.

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).


Eligibility criteria: Inclusion Criteria:

1. Women of more than 18 years old (menopause or not).
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:

1. Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
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.

Primary outcomes:
measure: Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.
timeFrame: 2 time points (D0 and D28) over a period of 2 years
Secondary outcomes:
measure: Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen
timeFrame: 2 time points (D0 and D28) over a period of 2 years
measure: Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase.
timeFrame: 2 time points (D0 and D28) over a period of 2 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius REGAUD
Study officials:
affiliation: Institut Claudius Regaud
name: Florence DALENC, MD
role: PRINCIPAL_INVESTIGATOR
References: