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: Clinical trial to study young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.

Condition	Treatment or Intervention
sexual dysfunction and infertility sexuality and reproductive issues psychosocial effects/treatment stage I breast cancer stage II breast cancer	Procedure: psychosocial assessment/care  Procedure: supportive care/therapy

Further Study Details: 

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.

Ages Eligible for Study:  up to  35 Years,  Genders Eligible for Study:  Both

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

Belgium
      Algemeen Ziekenhuis Sint-Augustinus, Wilrijk,  2610,  Belgium; Recruiting
      Centre Hospitalier Etterbeek Ixelles, Brussels,  B-1050,  Belgium; Recruiting
      CHU Liege - Domaine Universitaire du Sart Tilman, LIEGE,  B-4000,  Belgium; Recruiting
      Institut Jules Bordet, Brussels,  1000,  Belgium; Recruiting
Croatia
      University Hospital Rebro, Zagreb,  41000,  Croatia; Recruiting
Germany
      Klinikum der J.W. Goethe Universitaet, Frankfurt,  D-60590,  Germany; Recruiting
Italy
      Ospedale Alessandro Manzoni, Lecco,  23900,  Italy; Recruiting
Lebanon
      American University of Beirut Medical Center, Beirut,  113-6044,  Lebanon; Recruiting
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
      Arnhems Radiotherapeutisch Instituut, ARNHEM,  6815 AD,  Netherlands; Recruiting
Peru
      Instituto de Enfermedades Neoplasicas, Lima,  34,  Peru; Recruiting
Portugal
      Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A., Lisboa,  1099-023 Codex,  Portugal; Recruiting
South Africa
      Groote Schuur Hospital, Cape Town,  7925,  South Africa; Recruiting
Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland; Recruiting
      Kantonsspital - St. Gallen, St. Gallen,  CH-9007,  Switzerland; Recruiting
Turkey
      Marmara University Hospital, Istanbul,  81190,  Turkey; Recruiting
Yugoslavia
      Institute of Oncology and Radiology of Serbia, BELGRADE,  11000,  Yugoslavia; Recruiting

Study chairs or principal investigators

Angelo Di Leo, MD,  Misericordia e Dolce Hospital   

Study ID Numbers:  CDR0000304757; EORTC-10002; BIG-3-98; NCT00062400
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00062400
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08