Breast CancerNCT00062400
Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer
A study testing psychosocial assessment and care in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 35 years, women only
- Conditions the study is for
- Breast Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction and Infertility
- What is being tested?
- psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 385 participants
- Where
- 27 sitesin 15 countries
- Study dates
- May 2003to Jun 2008
- Phase
- Interventional
- 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 0 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
27 sites in 15 countries.
27 sites in 15 countries
Belgium4 sites
Institut Jules Bordet
Brussels, 1000
Centre Hospitalier Etterbeek Ixelles
Brussels, B-1050
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, B-4000
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, 2610
Italy4 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Azienda Istituti Ospitalieri
Cremona, 26100
Ospedale Alessandro Manzoni
Lecco, 23900
European Institute of Oncology
Milan, 20141
Chile3 sites
Instituto de Radiomedicina
Santiago, 10
Clinica Alemana
Santiago, 5951
Hospital Militar
Santiago
Switzerland3 sites
Inselspital Bern
Bern, CH-3010
Ospedale Beata Vergine
Mendrisio, CH-6850
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
Germany2 sites
Klinikum der J.W. Goethe Universitaet
Frankfurt, D-60590
Universitatsklinikum Heidelberg
Heidelberg, 69115
Netherlands2 sites
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Arnhems Radiotherapeutisch Instituut
Arnhem, 6815 AD
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Lisbon, 1099-023 Codex
About this study
Official title: 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.
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.
- Conditions
- Breast Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction and Infertility, Sexuality and Reproductive Issues
- Being tested
- psychosocial assessment and care
- 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
- Medical subject headings
- Breast Neoplasms, Sexual Dysfunction, Physiological, Infertility, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMay 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- German Adjuvant Breast Cancer Group, ETOP IBCSG Partners Foundation
- Responsible party
- Sponsor
- Investigators
- Zora Neskovic-Konstantinovic, Study chair, Institute Of Oncology & Radiology, Belgrade, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062400
- Sponsor's protocol ID
- EORTC-10002
- Other IDs
- EORTC-10002, BIG-3-98, IBCSG-29-03
- Status last verified
- Oct 2013
- First submitted
- 5 Jun 2003
- Last updated
- 12 May 2026
- Results posted
- No
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 at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00062400
- Acronym / sponsor ID
- EORTC-10002
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- German Adjuvant Breast Cancer Group, ETOP IBCSG Partners Foundation
- Study start
- May 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
Who may qualify
- Ages
- 0 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publicationNeskovic-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zora Neskovic-Konstantinovic study chair
Institute Of Oncology & Radiology, Belgrade, Serbia
27 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial assessment and care in people with Breast Cancer and Psychosocial Effects of Cancer and Its Treatment, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Belgium, Italy, Chile, Switzerland, Germany and 10 more countries. 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?
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire. 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 NCT00062400, which also lists 1 linked publication.
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 12 May 2026.