Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not (OXYTAM)

Institut Claudius Regaud

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Exemestane; Drug: Letrozole; Drug: Tamoxifen,; Drug: Anastrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT01553903

11 SEIN 09

Details and patient eligibility

About

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).

Enrollment: 29 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

Tamoxifen,

Experimental group

Description:

Current hormonotherapy treatment in hormone dependent breast cancer

Treatment:

Drug: Tamoxifen,

Exemestane

Experimental group

Description:

Current hormonotherapy treatment in hormone dependent breast cancer

Treatment:

Drug: Exemestane

Anastrozole

Experimental group

Description:

Current hormonotherapy treatment in hormone dependent breast cancer

Treatment:

Drug: Anastrozole

Letrozole

Experimental group

Description:

Current hormonotherapy treatment in hormone dependent breast cancer

Treatment:

Drug: Letrozole