Clinical trial NCT00293540: Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: metastatic
secondary
Hormone Receptor-Positive Breast Cancer
Lead sponsor: International Breast Cancer Research Foundation
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2006-02-17
Enrollment: 249
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Current oral contraceptives

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College Hospital
city: Shijiazhuang
country: China
facility: 4th Hospital of Hebei Medical University
state: Hebei
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Cancer Institute
city: Beijing
country: China
facility: Choa Yang Capital Institute
city: Beijing
country: China
facility: National Railroad
city: Beijing
country: China
facility: Peoples Hospital
city: Ji Nan
country: China
facility: Qilu Hospital
city: Shanghai
country: China
facility: Fudan University
city: Hyderabaad
country: India
facility: Nizam's Institute
city: Jakarta
country: Indonesia
facility: Dr. Ciptomanounkusumo General Hospital
city: Kuala Lumpur
country: Malaysia
facility: UN. Mayala
city: Rabat
country: Morocco
facility: National Institute of Oncology
city: Ibadan
country: Nigeria
facility: University College Hospital
city: Manila
country: Philippines
facility: East Avenue Medical Center
city: Manila
country: Philippines
facility: Jose Reyes
city: Manila
country: Philippines
facility: Philippines General Hospital
city: Manila
country: Philippines
facility: Rizal
city: Manila
country: Philippines
facility: Vicente Sotto Hospital
city: Hanoi
country: Vietnam
facility: Hospital K
Study officials:
affiliation: Ohio State University
name: Richard R. Love, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Love RR, Hossain SM, Hussain MM, Mostafa MG, Laudico AV, Siguan SS, Adebamowo C, Sun JZ, Fei F, Shao ZM, Liu Y, Akram Hussain SM, Zhang B, Cheng L, Panigaro S, Walta F, Chuan JH, Mirasol-Lumague MR, Yip CH, Navarro NS Jr, Huang CS, Lu YS, Ferdousy T, Salim R, Akhter C, Nahar S, Uy G, Young GS, Hade EM, Jarjoura D. Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer. Eur J Cancer. 2016 Jun;60:107-16. doi: 10.1016/j.ejca.2016.03.011. Epub 2016 Apr 20.