ClinicalTrials.gg
CompletedNCT02862990Updated Oct 5, 2020

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

An observational study in Breast Cancer and Fertility, sponsored by Latin American Cooperative Oncology Group. Completed at 7 sites in 5 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by Latin American Cooperative Oncology Group · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
343
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Breast Cancer
  • Fertility

Browse trials for

Keywords

  • Breast cancer
  • Fertility
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's enrollment of 343 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Latin American Cooperative Oncology Group is the lead sponsor of 48 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pre menopausal women diagnosed with breast cancer prior treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women with age ≥ 18 and ≤ 40
  • Indication of (neo) chemotherapy
  • Prior chemotherapy treatment
  • Patients with menstrual periods in the last 6 months
  • In use of methods
  • Without breast cancer recurrence
  • Capacity to read and understand the

Exclusion criteria

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 .
  • Previous diagnosis of infertility
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
343 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre menopausal women with breast cancer

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

06

What researchers measure

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

    Time frame: Baseline and 1 year after after the first interview

Secondary outcomes

  1. Infertility risk for breast cancer patients after accepting chemotherapy

    Time frame: Baseline and 1 year after the first interview

  2. Minimal percentage of cure necessary for patients accept the chemotherapy treatment

    Time frame: Baseline and 1 year after the first interview

  3. Age when diagnosed

    Time frame: Baseline and 1 year after the first interview

  4. Number of children

    Time frame: Baseline and 1 year after the first interview

  5. Desire to have kids

    Time frame: Baseline and 1 year after the first interview

  6. Marital status

    Time frame: Baseline

  7. Scholarity

    Time frame: Baseline

  8. Period of time since the diagnosis

    Time frame: Baseline

  9. Chemotherapy scheme administration

    Time frame: Baseline and 1 year after the first interview

  10. Period of time from the last menstruation period

    Time frame: Baseline and 1 year after the first interview

  11. Description of quality of life of patients with the EORTC QLQ-BR23

    Time frame: Baseline and 1 year after the first interview

07

Study locations

7 sites
  • 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 de Lerdo, Mexico
  • INEN
    Surquillo, Peru
  • Hospital de Clínicas San Agustín
    Puerto Cabello, Venezuela
08

References and documents

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. PubMed 20610543 ↗
  • 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. PubMed 19394537 ↗
  • 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. PubMed 23116682 ↗
  • 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. PubMed 11886005 ↗
  • 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. PubMed 7999454 ↗
  • 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. PubMed 24038775 ↗
  • Gradishar WJ, Schilsky RL. Ovarian function following radiation and chemotherapy for cancer. Semin Oncol. 1989 Oct;16(5):425-36. No abstract available. PubMed 2678491 ↗
  • 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. PubMed 17036039 ↗
  • 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. PubMed 6687378 ↗
  • 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. PubMed 14512398 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Jun 2020 and a completion of Jun 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2016
First posted
Aug 11, 2016
Start
May 2015
Primary completionActual
Jun 15, 2020
CompletionActual
Jun 15, 2020
Last update
Oct 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02862990
Lead sponsor
Latin American Cooperative Oncology Group
Collaborators
Grupo de Estudios Clínicos Oncológicos Peruano
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
May 2015
Primary completion
Jun 15, 2020
Completion
Jun 15, 2020
Last update
Oct 5, 2020

Study contacts

Gustavo Werutsky, MD
study director · Latin American Cooperative Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion