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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862990
• Other study ID #: LACOG 0414
• Status: Completed
• Start date: May 2015
• Est. completion date: June 15, 2020

Study information

• Verified date: October 2020
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fertility

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Grupo de Estudios Clínicos Oncológicos Peruano

Countries where clinical trial is conducted

Brazil,  Cuba,  Mexico,  Peru,  Venezuela, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Colleoni M, Rotmensz N, Robertson C, Orlando L, Viale G, Renne G, Luini A, Veronesi P, Intra M, Orecchia R, Catalano G, Galimberti V, Nolé 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. — View Citation

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. — View Citation

Gradishar WJ, Schilsky RL. Ovarian function following radiation and chemotherapy for cancer. Semin Oncol. 1989 Oct;16(5):425-36. Review. — View Citation

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. — View Citation

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)

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. Review. — View Citation

Senkus E, Gomez H, Dirix L, Jerusalem G, Murray E, Van Tienhoven G, Westenberg AH, Bottomley A, Rapion J, Bogaerts J, Di Leo A, Neškovic-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. — View Citation

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. Epub 2006 Oct 12. Review. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infertility risk for breast cancer patients after accepting chemotherapy		Baseline and 1 year after the first interview
Secondary	Minimal percentage of cure necessary for patients accept the chemotherapy treatment		Baseline and 1 year after the first interview
Secondary	Age when diagnosed		Baseline and 1 year after the first interview
Secondary	Number of children		Baseline and 1 year after the first interview
Secondary	Desire to have kids		Baseline and 1 year after the first interview
Secondary	Marital status		Baseline
Secondary	Scholarity		Baseline
Secondary	Period of time since the diagnosis		Baseline
Secondary	Chemotherapy scheme administration		Baseline and 1 year after the first interview
Secondary	Period of time from the last menstruation period		Baseline and 1 year after the first interview
Secondary	Description of quality of life of patients with the EORTC QLQ-BR23		Baseline and 1 year after the first interview

External 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