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Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05049031
Acronym
IMPACTTHKS
Enrollment
102
Registered
2021-09-17
Start date
2021-10-06
Completion date
2022-02-01
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHERQuestionnaire

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the bone impact of hormone therapy remotelyInclusion 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 remotelyInclusion day (day 0)A questionnaire asking patients if they have had a cardiovascular problem since stopping treatment will be offered.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026