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):
International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier:
NCT00201851
First received: September 12, 2005
Last updated: March 14, 2014
Last verified: March 2014

September 12, 2005
March 14, 2014
January 2004
December 2011   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: two- to three-year accrual and initial two or more years of follow-up period ] [ Designated as safety issue: No ]
Not Provided
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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
  • Active Comparator: Immediate surgery
    Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
    Interventions:
    • Drug: Tamoxifen
    • Procedure: Surgery: Oophorectomy
  • Experimental: Scheduled surgery
    Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
    Interventions:
    • Drug: Tamoxifen
    • Procedure: Surgery: Oophorectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
740
Not Provided
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
International Breast Cancer Research Foundation
International Breast Cancer Research Foundation
Not Provided
Principal Investigator: Richard R. Love, M.D. Ohio State University
International Breast Cancer Research Foundation
March 2014

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