Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk After Initial Treatment in Patients With Non-metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast cancer treated with hormone therapy<br>Adult patients with T1-T3, N0-N2, M0 breast cancer and referred to the Menopause Center of Toulouse Hospital for their breast cancer | Other: Questionnaire<br>* A questionnaire will be given to patients who will ask them about their possible fractures, their bone and oncological follow-ups and their possible cardiovascular events since the end of treatment with hormone therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

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