Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

Breast Cancer Clinical Trial

— IMPACTTHKS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049031
• Other study ID #: RC31/21/0368
• Status: Completed
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)