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

This study is currently recruiting patients.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Study of Attitudes Toward the Risk of Infertility Related to Adjuvant Therapy in Women With Early Breast Cancer

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.

Eligibility

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

Location and Contact Information


Belgium
      Algemeen Ziekenhuis Sint-Augustinus, Wilrijk,  2610,  Belgium; Recruiting
Contact Person  32-3-443-37-37 

      Centre Hospitalier Etterbeek Ixelles, Brussels,  B-1050,  Belgium; Recruiting
Contact Person  32-641-4111 

      CHU Liege - Domaine Universitaire du Sart Tilman, LIEGE,  B-4000,  Belgium; Recruiting
Contact Person  32-4-366-7111 

      Institut Jules Bordet, Brussels,  1000,  Belgium; Recruiting
Contact Person  32-2-541-3181 

Croatia
      University Hospital Rebro, Zagreb,  41000,  Croatia; Recruiting
Contact Person  385-1-238-8644 

Germany
      Klinikum der J.W. Goethe Universitaet, Frankfurt,  D-60590,  Germany; Recruiting
Contact Person  49-69-6301-5744 

Italy
      Ospedale Alessandro Manzoni, Lecco,  23900,  Italy; Recruiting
Contact Person

Lebanon
      American University of Beirut Medical Center, Beirut,  113-6044,  Lebanon; Recruiting
Contact Person  961-1-350-000 

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
Contact Person  31-20-566-9111 

      Arnhems Radiotherapeutisch Instituut, ARNHEM,  6815 AD,  Netherlands; Recruiting
Contact Person  31-26-371-2412 

Peru
      Instituto de Enfermedades Neoplasicas, Lima,  34,  Peru; Recruiting
Contact Person  51-1-612-9700 

Portugal
      Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A., Lisboa,  1099-023 Codex,  Portugal; Recruiting
Contact Person  351-21-722-9800 

South Africa
      Groote Schuur Hospital, Cape Town,  7925,  South Africa; Recruiting
Contact Person  27-21-404-4265 

Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland; Recruiting
Contact Person  41-31-632-2243 

      Kantonsspital - St. Gallen, St. Gallen,  CH-9007,  Switzerland; Recruiting
Contact Person  41-71-494-1062 

Turkey
      Marmara University Hospital, Istanbul,  81190,  Turkey; Recruiting
Contact Person  90-327-5050 

Yugoslavia
      Institute of Oncology and Radiology of Serbia, BELGRADE,  11000,  Yugoslavia; Recruiting
Contact Person  381-361-4660 

Study chairs or principal investigators

Angelo Di Leo, MD,  Misericordia e Dolce Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005