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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02862990
Enrollment
343
Registered
2016-08-11
Start date
2015-05-31
Completion date
2020-06-15
Last updated
2020-10-05

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

Conditions

Breast Cancer, Fertility

Keywords

Breast cancer, Fertility

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

Grupo de Estudios Clínicos Oncológicos Peruano
CollaboratorOTHER
Latin American Cooperative Oncology Group
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertilityBaseline and 1 year after after the first interview

Secondary

MeasureTime frame
Minimal percentage of cure necessary for patients accept the chemotherapy treatmentBaseline and 1 year after the first interview
Age when diagnosedBaseline and 1 year after the first interview
Number of childrenBaseline and 1 year after the first interview
Desire to have kidsBaseline and 1 year after the first interview
Marital statusBaseline
Infertility risk for breast cancer patients after accepting chemotherapyBaseline and 1 year after the first interview
Period of time since the diagnosisBaseline
Chemotherapy scheme administrationBaseline and 1 year after the first interview
Period of time from the last menstruation periodBaseline and 1 year after the first interview
Description of quality of life of patients with the EORTC QLQ-BR23Baseline and 1 year after the first interview
ScholarityBaseline

Countries

Brazil, Cuba, Mexico, Peru, Venezuela

Outcome results

None listed

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