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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00062400

Enrollment

385

Registered

2003-06-06

Start date

2003-05-01

Completion date

2008-06-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction and Infertility, Sexuality and Reproductive Issues

Keywords

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

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.

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.

Interventions

PROCEDUREpsychosocial assessment and care

Study design

Primary purpose

OTHER

Eligibility

Sex/Gender

FEMALE

Age

0 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire	—

Countries

Belgium, Chile, Croatia, Germany, Italy, Lebanon, Netherlands, Peru, Poland, Portugal, Serbia, South Africa, Switzerland, Turkey (Türkiye), United Kingdom

Contacts

STUDY_CHAIRZora Neskovic-Konstantinovic

Institute Of Oncology & Radiology, Belgrade, Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026