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

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ClinicalTrials.gov Identifier: NCT00062400
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : October 24, 2013
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

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Psychosocial Effects of Cancer and Its Treatment Sexual Dysfunction and Infertility Sexuality and Reproductive Issues Procedure: psychosocial assessment and care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 385 participants
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
Study Start Date : May 2003
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Patients who would agree to have chemotherapy if it reduces their chances of having children as assessed by questionnaire


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
BIG-3-98
IBCSG-29-03
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female