Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

Evaluate the bone impact of hormone therapy remotely

Time frame: 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

Time frame: Inclusion day (day 0)

A questionnaire asking patients if they have had a cardiovascular problem since stopping treatment will be offered.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: IMPACTTHKS

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 17, 2021
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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