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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201851
• Other study ID #: OSU-0483
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 13, 2015
• Start date: January 2004
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: International Breast Cancer Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: May 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Open for accrual in Asia only

• Female age 18-50,

• premenopausal with regular cycles (>25-35 in length)

• fine-needle aspiration diagnosis

• Stage II-IIIA hormone receptor positive invasive breast cancer

• No prior radiation or chemotherapy

• Must be surgical candidate for bilateral oophorectomy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen
20 mg po daily x 5 years

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)

Locations

Country	Name	City	State
Morocco	National Institute of Oncology	Rabat
Philippines	Vicente Soto Memorial Medical Center	Cebu
Philippines	East Avenue Medical Center	Manila
Philippines	Philippine General Hospital	Manila
Philippines	Rizal	Manila
Philippines	Santo Toma Hospital	Manila
Vietnam	Danang General	Danang
Vietnam	Hospital K, National Cancer Institute	Hanoi
Vietnam	Hue Central	Hue

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Research Foundation

Countries where clinical trial is conducted

Morocco,  Philippines,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival	5-year disease-free survival	two- to three-year accrual and initial two or more years of follow-up period	No