IMPACTTHKS: Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT05049031

Collaborator

(none)

102

Enrollment

Location

Arm

3.9

Actual Duration (Months)

26.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Questionnaire	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 6, 2021

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breast cancer treated with hormone therapy Adult patients with T1-T3, N0-N2, M0 breast cancer and referred to the Menopause Center of Toulouse Hospital for their breast cancer	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.

Arm

Intervention/Treatment

Experimental: Breast cancer treated with hormone therapy

Adult patients with T1-T3, N0-N2, M0 breast cancer and referred to the Menopause Center of Toulouse Hospital for their breast cancer

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Toulouse	Toulouse		France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Anna Gosset, MD, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT05049031

Other Study ID Numbers:

RC31/21/0368

First Posted:

Sep 17, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Mar 2, 2022