Clinical trial NCT00062400: Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: German Adjuvant Breast Cancer Group
name: ETOP IBCSG Partners Foundation
First posted: 2003-06-06
Enrollment: 385
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Centre Hospitalier Etterbeek Ixelles
city: Liege
country: Belgium
facility: CHU Liege - Domaine Universitaire du Sart Tilman
city: Wilrijk
country: Belgium
facility: Algemeen Ziekenhuis Sint-Augustinus
city: Santiago
country: Chile
facility: Instituto de Radiomedicina
city: Santiago
country: Chile
facility: Clinica Alemana
city: Santiago
country: Chile
facility: Hospital Militar
city: Zagreb
country: Croatia
facility: University Hospital Rebro
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe Universitaet
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Milan
country: Italy
facility: European Institute of Oncology
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum at University of Amsterdam
city: Arnhem
country: Netherlands
facility: Arnhems Radiotherapeutisch Instituut
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Mendrisio
country: Switzerland
facility: Ospedale Beata Vergine
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Istanbul
country: Turkey
facility: Marmara University Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Scotland
Study officials:
affiliation: Institute Of Oncology & Radiology, Belgrade, Serbia
name: Zora Neskovic-Konstantinovic
role: STUDY_CHAIR
References:
citation: 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.