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Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201851
First received: September 12, 2005
Last updated: November 22, 2011
Last verified: November 2011
History of Changes

September 12, 2005
November 22, 2011
January 2004
December 2011   (final data collection date for primary outcome measure)
evaluate the impact of the timing in the menstrual cycle of simultaneous mastectomy and oophorectomy on disease-free survival from operable breast cancer. [ Time Frame: two- to three-year accrual and initial two or more years of follow-up period ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00201851 on ClinicalTrials.gov Archive Site
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Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer

This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
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Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Tamoxifen
    20 mg po daily x 5 years
    Other Name: Nolvadex®
  • Procedure: Surgery: Oophorectomy
    Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
    Other Name: ovary removal surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1
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December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Open for accrual in Asia only
  • Female age 18-50,
  • premenopausal with regular cycles (>25-35 in length)
  • FNA diagnosis
  • Stage II-IIIA HR+ invasive breast cancer
  • No prior radiation or chemotherapy
  • Must be surgical candidate for bilateral oophorectomy
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Morocco,   Philippines,   Vietnam
 
NCT00201851
OSU-0483
Yes
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Richard R. Love, M.D. Ohio State University
Ohio State University Comprehensive Cancer Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP