5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma

Breast Cancer Clinical Trial

— HACAMI  

Official title:

5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791750
• Other study ID #: ICL OBS 02
• Status: Completed
• Start date: June 3, 2016
• Est. completion date: June 3, 2017

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 3, 2017
• Est. primary completion date: June 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy

• Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy

• Adult patients

• Being capable and agree to follow the study procedure

• Patients informed and non-opposed

• Covered by social security

Exclusion Criteria:

• History of other cancer except basal cell carcinoma

• Patients with breast invasive carcinoma negative-RH

• Synchronous metastases

• Relapsed

• Previous adjuvant hormonal therapy

• Men

• Patients with guardianship

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• questionnary of quality of life

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre lès Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors associated with persistence to hormone therapy for breast cancer	Women will be classed as persistent if they don't discontinue or abandon hormone therapy during the 5 years after the introduction of the medication. The information will be recorded thanks to a self-questionnary fulfilled the inclusion day.; The baseline characteristics will be compared between persistent women and non-persistent women.	1 day
Secondary	Comparison of the quality of life	Quality of life between patients who continued hormone therapy for 5 years and patients who discontinued treatment early will be searched for using the questionnaire	1 day
Secondary	Proportion of women with a change in their treatment	Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.	1 day
Secondary	Cause of treatment discontinuation	In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.	1 day
Secondary	Continued homonotherapy	In the subgroup of women who have been treated with hormone therapy for 5 years, determine the proportion of women not opposed to the continuation of hormone therapy beyond 5 years	1 day