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

NCT02862990 | Completed

• 1 other identifier: LACOG 0414
• Study Type: observational
• Target: 343
• Locations: 5 countries
• Sites: 7

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.

Conditions

Breast Cancer; Fertility

Keywords

Breast cancer; Fertility

Outcome Measures

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

  Baseline and 1 year after after the first interview

Secondary Outcomes (11)

• Infertility risk for breast cancer patients after accepting chemotherapy

  Baseline and 1 year after the first interview

• Minimal percentage of cure necessary for patients accept the chemotherapy treatment

  Baseline and 1 year after the first interview

• Age when diagnosed

  Baseline and 1 year after the first interview

• Number of children

  Baseline and 1 year after the first interview

• Desire to have kids

  Baseline and 1 year after the first interview

Study Arms (1)

Pre menopausal women with breast cancer

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pre menopausal women diagnosed with breast cancer prior treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Grupo de Estudios Clínicos Oncológicos Peruano: collaborator

Study Sites (7)

CPO - Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Location

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Pérola Byington

São Paulo, Brazil

Location

Instituto Nacional de Oncologia y Radiobiologia

Havana, Cuba

Location

Cenro Oncologico Estatal ISSEMYM

Toluca, Mexico

Location

INEN

Surquillo, Peru

Location

Hospital de Clínicas San Agustín

Puerto Cabello, Venezuela

Location

Related Publications (13)

• Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.

  PMID: 20610543 BACKGROUND

• Benson JR, Jatoi I, Keisch M, Esteva FJ, Makris A, Jordan VC. Early breast cancer. Lancet. 2009 Apr 25;373(9673):1463-79. doi: 10.1016/S0140-6736(09)60316-0.

  PMID: 19394537 BACKGROUND

• Cardoso F, Loibl S, Pagani O, Graziottin A, Panizza P, Martincich L, Gentilini O, Peccatori F, Fourquet A, Delaloge S, Marotti L, Penault-Llorca F, Kotti-Kitromilidou AM, Rodger A, Harbeck N; European Society of Breast Cancer Specialists. The European Society of Breast Cancer Specialists recommendations for the management of young women with breast cancer. Eur J Cancer. 2012 Dec;48(18):3355-77. doi: 10.1016/j.ejca.2012.10.004. Epub 2012 Oct 29.

  PMID: 23116682 BACKGROUND

• Colleoni M, Rotmensz N, Robertson C, Orlando L, Viale G, Renne G, Luini A, Veronesi P, Intra M, Orecchia R, Catalano G, Galimberti V, Nole F, Martinelli G, Goldhirsch A. Very young women (<35 years) with operable breast cancer: features of disease at presentation. Ann Oncol. 2002 Feb;13(2):273-9. doi: 10.1093/annonc/mdf039.

  PMID: 11886005 BACKGROUND

• Vallejos Sologuren C, Gómez HL, et al. Clinicopathologic and outcome variables of worse prognosis in premenopausal patients (pts) age 35 and younger. 2010 Breast Cancer Symposium. Abstract 65

  BACKGROUND

• Reichman BS, Green KB. Breast cancer in young women: effect of chemotherapy on ovarian function, fertility, and birth defects. J Natl Cancer Inst Monogr. 1994;(16):125-9.

  PMID: 7999454 BACKGROUND

• Senkus E, Gomez H, Dirix L, Jerusalem G, Murray E, Van Tienhoven G, Westenberg AH, Bottomley A, Rapion J, Bogaerts J, Di Leo A, Neskovic-Konstantinovic Z. Attitudes of young patients with breast cancer toward fertility loss related to adjuvant systemic therapies. EORTC study 10002 BIG 3-98. Psychooncology. 2014 Feb;23(2):173-82. doi: 10.1002/pon.3384. Epub 2013 Aug 29.

  PMID: 24038775 BACKGROUND

• Gradishar WJ, Schilsky RL. Ovarian function following radiation and chemotherapy for cancer. Semin Oncol. 1989 Oct;16(5):425-36. No abstract available.

  PMID: 2678491 BACKGROUND

• Stearns V, Schneider B, Henry NL, Hayes DF, Flockhart DA. Breast cancer treatment and ovarian failure: risk factors and emerging genetic determinants. Nat Rev Cancer. 2006 Nov;6(11):886-93. doi: 10.1038/nrc1992. Epub 2006 Oct 12.

  PMID: 17036039 BACKGROUND

• Dnistrian AM, Schwartz MK, Fracchia AA, Kaufman RJ, Hakes TB, Currie VE. Endocrine consequences of CMF adjuvant therapy in premenopausal and postmenopausal breast cancer patients. Cancer. 1983 Mar 1;51(5):803-7. doi: 10.1002/1097-0142(19830301)51:53.0.co;2-v.

  PMID: 6687378 BACKGROUND

• Moore HCF, et al. Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in earlystage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance). J Clin Oncol 32:5s, 2014 (suppl; abstr LBA505)

  BACKGROUND

• Brandberg Y, Michelson H, Nilsson B, Bolund C, Erikstein B, Hietanen P, Kaasa S, Nilsson J, Wiklund T, Wilking N, Bergh J; Scandinavian Breast Group Study 9401. Quality of life in women with breast cancer during the first year after random assignment to adjuvant treatment with marrow-supported high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin or tailored therapy with Fluorouracil, epirubicin, and cyclophosphamide: Scandinavian Breast Group Study 9401. J Clin Oncol. 2003 Oct 1;21(19):3659-64. doi: 10.1200/JCO.2003.07.020.

  PMID: 14512398 BACKGROUND

• 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.

  PMID: 41049579 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gustavo Werutsky, MD

  Latin American Cooperative Oncology Group

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: August 11, 2016
• Study Start: May 1, 2015
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

BR (3); VE (1); ME (1); PE (1); CU (1)