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Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer


Phase 3
18 Years
50 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

two- to three-year accrual and initial two or more years of follow-up period

Safety Issue:

No

Principal Investigator

Richard R. Love, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0483

NCT ID:

NCT00201851

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Asian
  • Premenopausal
  • Women
  • Oophorectomy
  • Breast Neoplasms

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