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Completed

NCT Number: NCT02791750

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnary of quality of life

Other

Primary outcomes

  1. Factors associated with persistence to hormone therapy for breast cancer

    Time frame: 1 day

    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.

Secondary outcomes

  1. Comparison of the quality of life

    Time frame: 1 day

    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

  2. Proportion of women with a change in their treatment

    Time frame: 1 day

    Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.

  3. Cause of treatment discontinuation

    Time frame: 1 day

    In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.

  4. Continued homonotherapy

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: HACAMI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 7, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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