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Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk (IMPACTTHKS)

T

Toulouse University Hospital

Status

Completed

Conditions

Breast Cancer

Treatments

Other: Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT05049031
RC31/21/0368

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

102 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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