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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062400
• Other study ID #: EORTC-10002
• Secondary ID: EORTC-10002BIG-3
• Status: Completed
• Phase: N/A
• First received: June 5, 2003
• Last updated: October 23, 2013
• Start date: May 2003

Study information

• Verified date: October 2013
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

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

Intervention

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Etterbeek Ixelles	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	CHU Liege - Domaine Universitaire du Sart Tilman	Liege
Belgium	Algemeen Ziekenhuis Sint-Augustinus	Wilrijk
Chile	Clinica Alemana	Santiago
Chile	Hospital Militar	Santiago
Chile	Instituto de Radiomedicina	Santiago
Croatia	University Hospital Rebro	Zagreb
Germany	Klinikum der J.W. Goethe Universitaet	Frankfurt
Germany	Universitatsklinikum Heidelberg	Heidelberg
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Azienda Istituti Ospitalieri	Cremona
Italy	Ospedale Alessandro Manzoni	Lecco
Italy	European Institute of Oncology	Milan
Lebanon	American University of Beirut Medical Center	Beirut
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	Arnhems Radiotherapeutisch Instituut	Arnhem
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Poland	Medical University of Gdansk	Gdansk
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA	Lisboa
Serbia	Institute of Oncology and Radiology of Serbia	Belgrade
South Africa	Groote Schuur Hospital	Cape Town
Switzerland	Inselspital Bern	Bern
Switzerland	Ospedale Beata Vergine	Mendrisio
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Turkey	Marmara University Hospital	Istanbul
United Kingdom	Western Infirmary	Glasgow	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	German Adjuvant Breast Cancer Group, International Breast Cancer Study Group

Countries where clinical trial is conducted

Belgium,  Chile,  Croatia,  Germany,  Italy,  Lebanon,  Netherlands,  Peru,  Poland,  Portugal,  Serbia,  South Africa,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (1)

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] 31

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire			No