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

This study has been completed.
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Richard R. Love, International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier:
NCT00293540
First received: February 15, 2006
Last updated: March 14, 2014
Last verified: March 2014

February 15, 2006
March 14, 2014
February 2006
February 2014   (final data collection date for primary outcome measure)
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. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00293540 on ClinicalTrials.gov Archive Site
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Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Procedure: oophorectomy
    Excision of an ovary
  • Drug: Tamoxifen
    20 mg orally every day
    Other Name: Nolvadex
  • Active Comparator: A
    Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen
    Interventions:
    • Procedure: oophorectomy
    • Drug: Tamoxifen
  • Active Comparator: B
    Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen
    Interventions:
    • Procedure: oophorectomy
    • Drug: Tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ER or PR positive breast cancer
  • Premenopausal with regular menstrual cycles

Exclusion Criteria:

  • Current oral contraceptives
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bangladesh,   China,   India,   Indonesia,   Malaysia,   Morocco,   Nigeria,   Philippines,   Vietnam
 
NCT00293540
OSU-0476
Yes
Richard R. Love, International Breast Cancer Research Foundation
International Breast Cancer Research Foundation
Breast Cancer Research Foundation
Principal Investigator: Richard R. Love, MD Ohio State University
International Breast Cancer Research Foundation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP