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Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: June 5, 2003   Last Updated: July 14, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062400
  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: 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 Intervention
Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
Sexual Dysfunction and Infertility
Sexuality and Reproductive Issues
 Procedure: psychosocial assessment and care

Study Type: Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Infertility
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire [ Designated as safety issue: No ]

Estimated Enrollment: 385
Study Start Date: May 2003
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062400

  Hide Study Locations
Locations
Belgium
Algemeen Ziekenhuis Sint-Augustinus Recruiting
Wilrijk, Belgium, 2610
Contact: Contact Person     32-3-443-37-37        
Centre Hospitalier Etterbeek Ixelles Recruiting
Brussels, Belgium, B-1050
Contact: Contact Person     32-641-4111        
CHU Liege - Domaine Universitaire du Sart Tilman Recruiting
Liege, Belgium, B-4000
Contact: Contact Person     32-4-366-7111        
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Contact Person     32-2-541-3181        
Chile
Clinica Alemana Recruiting
Santiago, Chile, 5951
Contact: Contact Person     Not Available        
Hospital Militar Recruiting
Santiago, Chile
Contact: Contact Person     Not Available        
Instituto de Radiomedicina Recruiting
Santiago, Chile, 10
Contact: Contact Person     56-2-754-1700        
Croatia
University Hospital Rebro Recruiting
Zagreb, Croatia, 41000
Contact: Contact Person     385-1-238-8644        
Germany
Klinikum der J.W. Goethe Universitaet Recruiting
Frankfurt, Germany, D-60590
Contact: Contact Person     49-69-6301-5744        
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Contact Person     49-6221-56-7029        
Italy
European Institute of Oncology Recruiting
Milan, Italy, 20141
Contact: Contact Person     39-02-5748-9861        
Centro di Riferimento Oncologico - Aviano Recruiting
Aviano, Italy, 33081
Contact: Contact Person     39-0434-659-111        
Azienda Istituti Ospitalieri Recruiting
Cremona, Italy, 26100
Contact: Contact Person     372-405111        
Ospedale Alessandro Manzoni Recruiting
Lecco, Italy, 23900
Contact: Contact Person     Not Available        
Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 113-6044
Contact: Contact Person     961-1-350-000        
Netherlands
Academisch Medisch Centrum at University of Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Contact Person     31-20-566-9111        
Arnhems Radiotherapeutisch Instituut Recruiting
Arnhem, Netherlands, 6815 AD
Contact: Contact Person     31-26-371-2412        
Peru
Instituto Nacional de Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Contact Person     51-1-612-9700        
Poland
Medical University of Gdansk Recruiting
Gdansk, Poland, 80-211
Contact: Contact Person     48-58-349-2000        
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA Recruiting
Lisboa, Portugal, 1099-023 Codex
Contact: Contact Person     351-21-722-9800        
Serbia
Institute of Oncology and Radiology of Serbia Recruiting
Belgrade, Serbia, 11000
Contact: Contact Person     381-361-4660        
South Africa
Groote Schuur Hospital Recruiting
Cape Town, South Africa, 7925
Contact: Contact Person     27-21-404-4265        
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, CH-3010
Contact: Contact Person     41-31-632-2243        
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Contact Person     41-71-494-1062        
Ospedale Beata Vergine Recruiting
Mendrisio, Switzerland, CH-6850
Contact: Contact Person     41-91-646-0101        
Turkey
Marmara University Hospital Recruiting
Istanbul, Turkey, 81190
Contact: Contact Person     90-327-5050        
United Kingdom, Scotland
Western Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: Contact Person     44-141-211-2000        
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Angelo Di Leo, MD Misericordia e Dolce Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.

Study ID Numbers: CDR0000304757, EORTC-10002, BIG-3-98
Study First Received: June 5, 2003
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00062400     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction and infertility
sexuality and reproductive issues
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Genital Diseases, Female
Infertility
Neoplasms
Neoplasms by Site
 Skin Diseases
Breast Neoplasms
Genital Diseases, Male
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009



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