Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

June 28, 2016 updated by: Richard R. Love, International Breast Cancer Research Foundation

Phase III Randomized Study of Luteal Phase vs. Follicular Phase Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor-Positive Breast Cancer

This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: Previous research suggests that women who have their ovaries removed as part of their treatment for breast cancer may live longer if the ovarian surgery is performed during the luteal phase (last 14 days of the menstrual cycle) rather than the follicular phase (the first 14 days of the menstrual cycle). The current study will evaluate this important research question in premenopausal women with metastatic hormone receptor-positive breast cancer who will be treated with surgery and tamoxifen.

Purpose: The purpose of this research is to find out if premenopausal women with breast cancer that has spread to other parts of the body live longer if their ovaries are removed during the second half of the menstrual cycle. This study will compare how long women live if they have their ovaries removed during the first half of their menstrual cycle (follicular phase) to how long women live if they have their ovaries removed during the second half of their menstrual cycle (luteal phase). Tamoxifen will also be given to study participants.

Treatment: Study participants will have tests performed in advance of surgery to remove their ovaries. Surgery will be performed within four weeks of these tests. The exact day will be determined by the study participant's menstrual history and by a process called randomization, which is a random decision making process to determine if each study participant will have their surgery during the first or second half of their menstrual cycle. On the day of surgery, blood will be taken immediately prior to surgery and three hours after surgery for hormone tests. After the surgery, study participants will be given tamoxifen in oral pills for daily consumption. Study participants will be asked to return to the hospital every two months for tests and distribution of additional tamoxifen tablets. Treatments will be discontinued for disease progression or unacceptable adverse effects.

Study Type

Interventional

Enrollment (Actual)

249

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

  • Bangladesh
      • Dhaka, Bangladesh
        • Dhaka Medical College Hospital
  • China
      • Beijing, China
        • Beijing Hospital
      • Beijing, China
        • Cancer Institute
      • Beijing, China
        • Choa Yang Capital Institute
      • Beijing, China
        • National Railroad
      • Beijing, China
        • Peoples Hospital
      • Ji Nan, China
        • Qilu hospital
      • Shanghai, China
        • Fudan University
    • Hebei
      • Shijiazhuang, Hebei, China
        • 4th Hospital of Hebei Medical University
  • India
      • Hyderabaad, India
        • Nizam's Institute
  • Indonesia
      • Jakarta, Indonesia
        • Dr. Ciptomanounkusumo General Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • UN. Mayala
  • Morocco
      • Rabat, Morocco
        • National Institute of Oncology
  • Nigeria
      • Ibadan, Nigeria
        • University College Hospital
  • Philippines
      • Manila, Philippines
        • East Avenue Medical Center
      • Manila, Philippines
        • Rizal
      • Manila, Philippines
        • Jose Reyes
      • Manila, Philippines
        • Philippines General Hospital
      • Manila, Philippines
        • Vicente Sotto Hospital
  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
  • Vietnam
      • Hanoi, Vietnam
        • Hospital K

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Estrogen receptor or progesterone receptor positive breast cancer
  • Premenopausal with regular menstrual cycles

Exclusion Criteria:

  • Current oral contraceptives

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen
Procedure: oophorectomy
Excision of an ovary
Drug: Tamoxifen
20 mg orally every day
Other Names:
  • Nolvadex
Active Comparator: B
Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen
Procedure: oophorectomy
Excision of an ovary
Drug: Tamoxifen
20 mg orally every day
Other Names:
  • Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 9 years
Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.
Up to 9 years

Collaborators and Investigators

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

Sponsor

International Breast Cancer Research Foundation

Collaborators

Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Richard R. Love, MD, Ohio State University

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

February 1, 2006

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-0476

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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