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

Show 27 Study Locations

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 27, 2009