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
N/A
35 Years
Female
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction and Infertility, Sexuality and Reproductive Issues
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
N/A
Outcome Measure:
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire
Safety Issue:
No
Principal Investigator
Zora Neskovic-Konstantinovic
Investigator Role:
Study Chair
Investigator Affiliation:
Institute Of Oncology & Radiology, Belgrade, Serbia
Authority:
United States: Federal Government
Study ID:
EORTC-10002
NCT ID:
NCT00062400
Start Date:
May 2003
Completion Date:
Related Keywords:
- Breast Cancer
- Psychosocial Effects of Cancer and Its Treatment
- Sexual Dysfunction and Infertility
- Sexuality and Reproductive Issues
- 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
- Breast Neoplasms
- Infertility
- Sexual Dysfunctions, Psychological
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