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AzTrials

Breast CancerNCT02862990

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

An observational study of Breast Cancer and Fertility, run by Latin American Cooperative Oncology Group at 7 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Breast Cancer, Fertility
How many people
343 participants
Where
7 sitesin 5 countries
Study dates
May 2015to 15 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Pre menopausal women diagnosed with breast cancer prior treatment

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 5 countries.

7 sites in 5 countries

Brazil3 sites

  • CPO - Pucrs

    Porto Alegre, Rio Grande do Sul

  • HCPA

    Porto Alegre, Rio Grande do Sul

  • Hospital Pérola Byington

    São Paulo

Other trials in Brazil

Cuba1 site

  • Instituto Nacional de Oncologia y Radiobiologia

    Havana

Other trials in Cuba

Mexico1 site

  • Cenro Oncologico Estatal ISSEMYM

    Toluca

Other trials in Mexico

Peru1 site

  • INEN

    Surquillo

Other trials in Peru

Venezuela1 site

  • Hospital de Clínicas San Agustín

    Puerto Cabello

Other trials in Venezuela

About this study

Official title: 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.

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
Keywords
Breast cancer, Fertility
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02862990
Study groupRoleWhat they receive
Pre menopausal women with breast cancerPre menopausal women with breast cancer prior treatment in face of infertility evoked by chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 1 year after after the first interview

Secondary outcomes (11)

  1. Infertility risk for breast cancer patients after accepting chemotherapy

    Measured: Baseline and 1 year after the first interview

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

    Measured: Baseline and 1 year after the first interview

  3. Age when diagnosed

    Measured: Baseline and 1 year after the first interview

  4. Number of children

    Measured: Baseline and 1 year after the first interview

  5. Desire to have kids

    Measured: Baseline and 1 year after the first interview

  6. Marital status

    Measured: Baseline

  7. Scholarity

    Measured: Baseline

  8. Period of time since the diagnosis

    Measured: Baseline

  9. Chemotherapy scheme administration

    Measured: Baseline and 1 year after the first interview

  10. Period of time from the last menstruation period

    Measured: Baseline and 1 year after the first interview

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

    Measured: Baseline and 1 year after the first interview

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startMay 2015
  3. Primary completion15 Jun 2020
  4. Study completion15 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02862990
Sponsor's protocol ID
LACOG 0414
Status last verified
Oct 2020
First submitted
27 Jan 2016
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    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

  • 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.

    PubMed 41049579

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Fertility, run by Latin American Cooperative Oncology Group at 7 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Brazil, Cuba, Mexico, Peru, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02862990, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

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