Completed

NCT Number: NCT00062400

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Genital Diseases Infertility Neoplasms Neoplasms by Site Psychosocial Effects of Cancer and Its Treatment Sexual Behavior Sexual Dysfunction and Infertility Sexual Dysfunction, Physiological Sexuality Sexuality and Reproductive Issues Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

0 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Etterbeek Ixelles, Brussels, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychosocial assessment and care

Procedure

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Collaborators

ETOP IBCSG Partners Foundation
German Adjuvant Breast Cancer Group

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2008
Study completion: 2008
First posted: Jun 6, 2003
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed