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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: oophorectomy; Drug: Tamoxifen

• Registration Number: NCT00293540
• Lead Sponsor: International Breast Cancer Research Foundation

Brief 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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-17
• Primary Completion: 2014-02
• Study Completion: 2015-03
• Results First Submitted: 2016-05-19
• Results First Submitted QC: 2016-05-19
• Status Verified: 2016-06
• Results First Posted: 2016-06-28
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 249

Inclusion Criteria

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

Read More

Exclusion Criteria

• Current oral contraceptives

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	oophorectomy	Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen
A	Tamoxifen	Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen
B	oophorectomy	Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen
B	Tamoxifen	Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen

Primary Outcome Measures

Name	Time	Method
Overall Survival	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.

Trial Locations

Locations (21)

National Railroad; 🇨🇳 Beijing, China

East Avenue Medical Center; 🇵🇭 Manila, Philippines

Vicente Sotto Hospital; 🇵🇭 Manila, Philippines

Qilu Hospital; 🇨🇳 Ji Nan, China

Cancer Institute; 🇨🇳 Beijing, China

Rizal; 🇵🇭 Manila, Philippines

Beijing Hospital; 🇨🇳 Beijing, China

University College Hospital; 🇳🇬 Ibadan, Nigeria

Fudan University; 🇨🇳 Shanghai, China

Nizam's Institute; 🇮🇳 Hyderabaad, India

Dr. Ciptomanounkusumo General Hospital; 🇮🇩 Jakarta, Indonesia

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Dhaka Medical College Hospital; 🇧🇩 Dhaka, Bangladesh

4th Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Choa Yang Capital Institute; 🇨🇳 Beijing, China

Peoples Hospital; 🇨🇳 Beijing, China

UN. Mayala; 🇲🇾 Kuala Lumpur, Malaysia

National Institute of Oncology; 🇲🇦 Rabat, Morocco

Jose Reyes; 🇵🇭 Manila, Philippines

Philippines General Hospital; 🇵🇭 Manila, Philippines

Hospital K; 🇻🇳 Hanoi, Vietnam