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

NCT00201851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2015-04-29

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • International Breast Cancer Research Foundation

    lead OTHER

Principal Investigators

  • Richard R. Love, M.D. · International Breast Cancer Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2011-12-31
Completion
2013-05-31

Countries

  • Morocco
  • Philippines
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201851 on ClinicalTrials.gov