RecruitingNot ApplicableNCT04740697

Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

Sponsor

Institut Claudius Regaud

Enrollment

200 participants

Start Date

Feb 12, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer. 200 patients will be included in the study. Each patient will be followed for one day.

Eligibility

Sex: FEMALEMin Age: 18 Months

Inclusion Criteria5

Age ≥ 18 years at entry into the study.
Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
Patients treated with tamoxifen for a maximum of 1 to 3 years.
Patient affiliated with a Social Security system in France.
Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria3

Pregnant or breastfeeding women.
Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Interventions

OTHERTreatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

Each included patient will be referred to the health care staff for a blood sample: * for the determination of the residual plasma concentration of tamoxifen and its active metabolites, * for the constitution of a biobank. Patients will then complete a questionnaire to collect information on tamoxifen intake and adherence (via the GIRERD questionnaire), as well as possible Alternative and Complementary Therapeutics (ACT) intake (reason for use, type of ACT, ...).