Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

NCT05049031 | Completed

• 1 other identifier: RC31/21/0368
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (1)

Breast cancer treated with hormone therapy

EXPERIMENTAL

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

Interventions

Questionnaire OTHER

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.

Breast cancer treated with hormone therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anna Gosset, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: October 6, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)