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

April 13, 2015 updated by: International Breast Cancer Research Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

740

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate surgery
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Drug: Tamoxifen
20 mg po daily x 5 years
Other Names:
  • 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 Names:
  • ovary removal surgery
Experimental: Scheduled surgery
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Drug: Tamoxifen
20 mg po daily x 5 years
Other Names:
  • 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 Names:
  • ovary removal surgery
Other: Immediate Surgery - nonrandomized
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Drug: Tamoxifen
20 mg po daily x 5 years
Other Names:
  • 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 Names:
  • ovary removal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: two- to three-year accrual and initial two or more years of follow-up period
5-year disease-free survival
two- to three-year accrual and initial two or more years of follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Richard R. Love, M.D., International Breast Cancer Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-0483

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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