ClinicalTrials.gg
CompletedNCT00062400Updated May 12, 2026

Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

An interventional study of psychosocial assessment and care in Breast Cancer, Psychosocial Effects of Cancer and Its Treatment and Sexual Dysfunction and Infertility, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 27 sites in 15 countries. Open to female participants aged 0 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
385
Ages
0 Years to 35 Years
Sex
Female
01

Study summary

RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.

PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.

Read the detailed description

OBJECTIVES:

  • Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
  • Correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation.

OUTLINE: This is a multicenter study.

Patients complete a questionnaire administered by a nontreating physician.

PROJECTED ACCRUAL: A total of 385 patients will be accrued for this study.

02

Conditions studied

  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sexual Dysfunction and Infertility
  • Sexuality and Reproductive Issues

Keywords

  • sexual dysfunction and infertility
  • sexuality and reproductive issues
  • psychosocial effects of cancer and its treatment
  • stage II breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
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 planned enrollment of 385 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 352 studies on the registry; 23 are open to participants now.

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

04

Who can participate

Ages eligible
0 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • or cytologically confirmed prior or current diagnosis of breast cancer

    • Stage I or II
    • No disease
  • No evidence of infertility

    • Regular menses or regular hormonal use for the past 3 months
  • Hormonal status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 35 and under at diagnosis

Sex

  • Female

Menopausal status

  • Premenopausal

Performance status

  • Not specified

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Not specified

Surgery

  • Not specified
Terms in these criteria, in plain language(4)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Other
Enrollment
385 participants (estimated)

Interventions

  • Procedurepsychosocial assessment and care
06

What researchers measure

Primary outcomes

  1. Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire

07

Study locations

27 sites
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • Centre Hospitalier Etterbeek Ixelles
    Brussels, B-1050, Belgium
  • CHU Liege - Domaine Universitaire du Sart Tilman
    Liège, B-4000, Belgium
  • Algemeen Ziekenhuis Sint-Augustinus
    Wilrijk, 2610, Belgium
  • Instituto de Radiomedicina
    Santiago, 10, Chile
  • Clinica Alemana
    Santiago, 5951, Chile
  • Hospital Militar
    Santiago, Chile
  • University Hospital Rebro
    Zagreb, 41000, Croatia
  • Klinikum der J.W. Goethe Universitaet
    Frankfurt, D-60590, Germany
  • Universitatsklinikum Heidelberg
    Heidelberg, 69115, Germany
  • Centro di Riferimento Oncologico - Aviano
    Aviano, 33081, Italy
  • Azienda Istituti Ospitalieri
    Cremona, 26100, Italy
  • Ospedale Alessandro Manzoni
    Lecco, 23900, Italy
  • European Institute of Oncology
    Milan, 20141, Italy
  • American University of Beirut Medical Center
    Beirut, 113-6044, Lebanon
  • Academisch Medisch Centrum at University of Amsterdam
    Amsterdam, 1105 AZ, Netherlands
  • Arnhems Radiotherapeutisch Instituut
    Arnhem, 6815 AD, Netherlands
  • Instituto Nacional de Enfermedades Neoplasicas
    Lima, 34, Peru
  • Medical University of Gdansk
    Gdansk, 80-211, Poland
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
    Lisbon, 1099-023 Codex, Portugal
  • Institute of Oncology and Radiology of Serbia
    Belgrade, 11000, Serbia
  • Groote Schuur Hospital
    Cape Town, 7925, South Africa
  • Inselspital Bern
    Bern, CH-3010, Switzerland
  • Ospedale Beata Vergine
    Mendrisio, CH-6850, Switzerland
  • Kantonsspital - St. Gallen
    Sankt Gallen, CH-9007, Switzerland
  • Marmara University Hospital
    Istanbul, 81190, Turkey (Türkiye)
  • Western Infirmary
    Glasgow, Scotland G11 6NT, United Kingdom
08

References and documents

Publications

  • Neskovic-Konstantinovic Z, Gomez H, Senkus-Konefka E, et al.: A Breast International Group survey of young breast cancer patients attitudes towards the risk of loss of fertility related to adjuvant therapies: EORTC protocol 10002 - BIG 3-98. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-3106, 2008.
09

Timeline

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

The record gives a start of May 2003, a primary completion of Jun 2008 and a completion of Jun 2008. 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
Jun 5, 2003
First posted
Jun 6, 2003
Start
May 2003
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Last update
May 12, 2026
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 May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00062400
Collaborators
German Adjuvant Breast Cancer Group, ETOP IBCSG Partners Foundation
Responsible party
Sponsor
First posted
Jun 6, 2003
Start date
May 2003
Primary completion
Jun 2008
Completion
Jun 2008
Last update
May 12, 2026

Study contacts

Zora Neskovic-Konstantinovic
study chair · Institute Of Oncology & Radiology, Belgrade, Serbia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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