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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Fertility

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

• Study Type: Observational
• Enrollment (Actual): 343

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Perola Byington
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • CPO - Pucrs
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • HCPA
• Cuba
  • Havana, Cuba
    • Instituto Nacional de Oncologia y Radiobiologia
• Mexico
  • Toluca de Lerdo, Mexico
    • Cenro Oncologico Estatal ISSEMYM
• Peru
  • Surquillo, Peru
    • INEN
• Venezuela
  • Puerto Cabello, Venezuela
    • Hospital de Clínicas San Agustín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pre menopausal women diagnosed with breast cancer prior treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pre menopausal women with breast cancer; Pre menopausal women with breast cancer prior treatment in face of infertility evoked by chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 infertility	Baseline and 1 year after after the first interview

Secondary Outcome Measures

Outcome Measure	Time Frame
Marital status	Baseline
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
Scholarity	Baseline
Period of time since the diagnosis	Baseline
Chemotherapy scheme administration	Baseline and 1 year after the first interview
Period of time from the last menstruation period	Baseline and 1 year after the first interview
Description of quality of life of patients with the EORTC QLQ-BR23	Baseline and 1 year after the first interview

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Grupo de Estudios Clínicos Oncológicos Peruano
• Investigators: Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

General Publications

• 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. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):133-4.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• Gradishar WJ, Schilsky RL. Ovarian function following radiation and chemotherapy for cancer. Semin Oncol. 1989 Oct;16(5):425-36. No abstract available.
• 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.
• 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.
• 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)
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; Fertility
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LACOG 0414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED