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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293540
• Other study ID #: OSU-0476
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2006
• Last updated: March 30, 2015
• Start date: February 2006
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: International Breast Cancer Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: March 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ER or PR positive breast cancer

• Premenopausal with regular menstrual cycles

Exclusion Criteria:

• Current oral contraceptives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• oophorectomy
Excision of an ovary

Drug:
• Tamoxifen
20 mg orally every day

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
International Breast Cancer Research Foundation	Breast Cancer Research Foundation

Countries where clinical trial is conducted

United States,  Vietnam,  Bangladesh,  China,  India,  Indonesia,  Malaysia,  Morocco,  Nigeria,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Every 3 months	No