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Completed

NCT Number: NCT02862990

Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy

To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CPO - Pucrs, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:

  • Age at diagnosis
  • Number of children
  • Will of having children
  • Marital status
  • Scholarity
  • Period of time from the diagnosis
  • Time of the last menstruation period
  • Chemotherapy administration
  • Clinical staging at the diagnosis
  • Pathological evaluation
  • Documentation of the cancer therapy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with age ≥ 18 and ≤ 40
  • Indication of (neo) adjuvant chemotherapy
  • Prior chemotherapy treatment
  • Patients with menstrual periods in the last 6 months
  • In use of contraceptive methods
  • Without breast cancer recurrence
  • Capacity to read and understand the informed consent

Exclusion criteria

  • Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
  • Patients whom initiated chemotherapy treatment before entering the study
  • Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
  • Previous diagnosis of infertility

Treatment and study plan

Primary outcomes

  1. To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility

    Time frame: Baseline and 1 year after after the first interview

Secondary outcomes

  1. Infertility risk for breast cancer patients after accepting chemotherapy

    Time frame: Baseline and 1 year after the first interview

  2. Minimal percentage of cure necessary for patients accept the chemotherapy treatment

    Time frame: Baseline and 1 year after the first interview

  3. Age when diagnosed

    Time frame: Baseline and 1 year after the first interview

  4. Number of children

    Time frame: Baseline and 1 year after the first interview

  5. Desire to have kids

    Time frame: Baseline and 1 year after the first interview

  6. Marital status

    Time frame: Baseline

  7. Scholarity

    Time frame: Baseline

  8. Period of time since the diagnosis

    Time frame: Baseline

  9. Chemotherapy scheme administration

    Time frame: Baseline and 1 year after the first interview

  10. Period of time from the last menstruation period

    Time frame: Baseline and 1 year after the first interview

  11. Description of quality of life of patients with the EORTC QLQ-BR23

    Time frame: Baseline and 1 year after the first interview

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Grupo de Estudios Clínicos Oncológicos Peruano

Registry information

Official study title

Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2016
Registry last updated
Oct 5, 2020

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

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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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