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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02791750
Acronym
HACAMI
Enrollment
150
Registered
2016-06-07
Start date
2016-06-03
Completion date
2017-06-03
Last updated
2018-08-08

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

Conditions

Breast Cancer

Keywords

hormone replacement therapy, breast cancer, follow up

Brief 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.

Interventions

OTHERquestionnary of quality of life

Sponsors

Institut de Cancérologie de Lorraine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Factors associated with persistence to hormone therapy for breast cancer1 dayWomen 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.

Secondary

MeasureTime frameDescription
Comparison of the quality of life1 dayQuality of life between patients who continued hormone therapy for 5 years and patients who discontinued treatment early will be searched for using the questionnaire
Proportion of women with a change in their treatment1 dayProportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.
Cause of treatment discontinuation1 dayIn the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.
Continued homonotherapy1 dayIn 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

Countries

France

Outcome results

None listed

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