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

May 7, 2026 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Survey of the Breast International Group (B.I.G.) to Assess the Attitude of Patients Aged Less Than 35 Years, With Early Breast Cancer, Toward the Risk of Loss of Fertility Related to Adjuvant Therapies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed prior or current diagnosis of breast cancer

    • Stage I or II
    • No relapsed disease

  • No evidence of infertility

    • Regular menses or regular hormonal contraception 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

Life expectancy

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

ETOP IBCSG Partners Foundation
German Adjuvant Breast Cancer Group

Investigators

  • Study Chair: Zora Neskovic-Konstantinovic, Institute Of Oncology & Radiology, Belgrade, Serbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 5, 2003

First Submitted That Met QC Criteria

June 5, 2003

First Posted (Estimated)

June 6, 2003

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10002
  • BIG-3-98
  • IBCSG-29-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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