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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: oophorectomy
Drug: Tamoxifen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Luteal Phase vs. Follicular Phase Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor-Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by International Breast Cancer Research Foundation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 249
Study Start Date: February 2006
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Nolvadex

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current oral contraceptives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293540

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Bangladesh
Dhaka Medical College Hospital
Dhaka, Bangladesh
China, Hebei
4th Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
China
Choa Yang Capital Institute
Beijing, China
National Railroad
Beijing, China
Beijing Hospital
Beijing, China
Cancer Institute
Beijing, China
Peoples Hospital
Beijing, China
Qilu Hospital
Ji Nan, China
Fudan University
Shanghai, China
India
Nizam's Institute
Hyderabaad, India
Indonesia
Dr. Ciptomanounkusumo General Hospital
Jakarta, Indonesia
Malaysia
UN. Mayala
Kuala Lumpur, Malaysia
Morocco
National Institute of Oncology
Rabat, Morocco
Nigeria
University College Hospital
Ibadan, Nigeria
Philippines
Philippines General Hospital
Manila, Philippines
Vicente Sotto Hospital
Manila, Philippines
Jose Reyes
Manila, Philippines
East Avenue Medical Center
Manila, Philippines
Rizal
Manila, Philippines
Vietnam
Hospital K
Hanoi, Vietnam
Sponsors and Collaborators
International Breast Cancer Research Foundation
Breast Cancer Research Foundation
Investigators
Principal Investigator: Richard R. Love, MD Ohio State University
  More Information

No publications provided

Responsible Party: Richard R. Love, Scientific director, International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier: NCT00293540     History of Changes
Other Study ID Numbers: OSU-0476
Study First Received: February 15, 2006
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by International Breast Cancer Research Foundation:
metastatic
secondary
Hormone Receptor-Positive Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Tamoxifen
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014