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

This study has been completed.
Sponsor:
Collaborators:
German Adjuvant Breast Cancer Group
International Breast Cancer Study Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00062400
First received: June 5, 2003
Last updated: October 23, 2013
Last verified: October 2013
  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:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

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
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062400

  Show 27 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
German Adjuvant Breast Cancer Group
International Breast Cancer Study Group
Investigators
Study Chair: Zora Neskovic-Konstantinovic Institute Of Oncology & Radiology, Belgrade, Serbia
  More Information

Additional Information:
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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00062400     History of Changes
Other Study ID Numbers: EORTC-10002, EORTC-10002, BIG-3-98, IBCSG-29-03
Study First Received: June 5, 2003
Last Updated: October 23, 2013
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

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

ClinicalTrials.gov processed this record on October 20, 2014