NCT04740697

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
21mo left

Started Feb 2021

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2021Feb 2028

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

February 2, 2021

Last Update Submit

April 17, 2026

Conditions

Breast Cancer

Keywords

Breast CancerTamoxifenAlternative and complementary therapiesTreatment adherenceTurmeric

Outcome Measures

Primary Outcomes (1)

  • Rate of patients who adhere to tamoxifen treatment.

    This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.

    18 months after the start of the research

Secondary Outcomes (3)

  • Rate of patients taking ACT.

    18 months after the start of the research

  • Rate of patients consuming turmeric-based dietary supplements.

    18 months after the start of the research

  • Plasma concentration of tamoxifen in patients.

    18 months after the start of the research

Study Arms (1)

Patient with localized breast cancer.

OTHER
Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

Interventions

Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.OTHER

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, ...).

Patient with localized breast cancer.

Eligibility Criteria

Age18 Months+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHealth BehaviorBehavior

Central Study Contacts

Florence DALENC

CONTACT

05 31 15 51 04dalenc.florence@iuct-oncopole.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

February 12, 2021

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

FR(1)