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Clinical Trials/NCT05049031
NCT05049031
Completed
Not Applicable

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

University Hospital, Toulouse1 site in 1 country102 target enrollmentOctober 6, 2021
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University Hospital, Toulouse
Enrollment
102
Locations
1
Primary Endpoint
Evaluate the bone impact of hormone therapy remotely
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 6, 2021
End Date
February 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

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.

Study Sites (1)

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