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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00062400

Collaborator

German Adjuvant Breast Cancer Group (Other), ETOP IBCSG Partners Foundation (Other)

385

Enrollment

Locations

14.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Sexuality and Reproductive Issues	Procedure: psychosocial assessment and care	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

385 participants

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 Start Date :

May 1, 2003

Actual Primary Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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