Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Questionnaire

• Registration Number: NCT05049031
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Breast cancer is the most frequently observed cancer in women in France.The mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.For patients with breast cancer expressing hormone receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming back.However, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-17
• Study Start: 2021-10-06
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• Adult patients who had T1-T3, N0-N2, M0 breast cancer
• Patients referred to the Menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 "Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast "
• Patient who has given her consent for the study (written or verbal) after clear and fair information

Exclusion Criteria

• Metastatic breast tumor
• Absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors
• Patients who have died since the last assessment
• Protected adult patient (guardianship, curatorship, safeguard of justice)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast cancer treated with hormone therapy	Questionnaire	Adult patients with T1-T3, N0-N2, M0 breast cancer and referred to the Menopause Center of Toulouse Hospital for their breast cancer

Primary Outcome Measures

Name	Time	Method
Evaluate the bone impact of hormone therapy remotely	Inclusion day (day 0)	A questionnaire asking patients if they have fractures since stopping the treatment will be offered.
Evaluate the cardiovascular impact of hormone therapy remotely	Inclusion day (day 0)	A questionnaire asking patients if they have had a cardiovascular problem since stopping treatment will be offered.

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France