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

NCT ID: NCT02862990

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 343 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-06-15

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

Conditions

Breast Cancer; Fertility

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pre menopausal women with breast cancer

Pre menopausal women with breast cancer prior treatment in face of infertility evoked by chemotherapy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Grupo de Estudios Clínicos Oncológicos Peruano

OTHER

Sponsor Role: collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Werutsky, MD

Role: STUDY_DIRECTOR

Latin American Cooperative Oncology Group

Locations

CPO - Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Pérola Byington

São Paulo, , Brazil

Instituto Nacional de Oncologia y Radiobiologia

Havana, , Cuba

Cenro Oncologico Estatal ISSEMYM

Toluca, , Mexico

INEN

Surquillo, , Peru

Hospital de Clínicas San Agustín

Puerto Cabello, , Venezuela

Countries

Brazil; Cuba; Mexico; Peru; Venezuela

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Werutsky G, Villarreal-Garza C, Gomez HL, Campos-Gomez S, Reyes RO, Liedke PER, Reinert T, Dybal V, Martinez-Mesa J, Nunes Filho PR, de Jesus RG, Zaffaroni F, Garcia VS, Seibel MF, Barrios P, Rocha MS, Barrios CH. Factors associated with accepting chemotherapy despite the risk of fertility loss in Latin American breast cancer patients-LACOG 0414 study. Ther Adv Med Oncol. 2025 Oct 2;17:17588359251378946. doi: 10.1177/17588359251378946. eCollection 2025.

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Related Links

http://globocan.iarc.fr/Default.aspx

Ferlay J, Shin HR, Bray F, et al. GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 \[Internet\]. Lyon, France: International Agency for Research on Cancer; 2010

Other Identifiers

LACOG 0414

Identifier Type: -

Identifier Source: org_study_id