Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
NCT ID: NCT00293540
Last Updated: 2016-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
249 participants
INTERVENTIONAL
2006-02-28
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen
oophorectomy
Excision of an ovary
Tamoxifen
20 mg orally every day
B
Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen
oophorectomy
Excision of an ovary
Tamoxifen
20 mg orally every day
Interventions
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oophorectomy
Excision of an ovary
Tamoxifen
20 mg orally every day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Premenopausal with regular menstrual cycles
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
International Breast Cancer Research Foundation
OTHER
Responsible Party
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Richard R. Love
Scientific director
Principal Investigators
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Richard R. Love, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University
Columbus, Ohio, United States
Dhaka Medical College Hospital
Dhaka, , Bangladesh
4th Hospital of Hebei Medical University
Shijiazhuang, Hebei, 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
Jinan, , China
Fudan University
Shanghai, , China
Nizam's Institute
Hyderabaad, , India
Dr. Ciptomanounkusumo General Hospital
Jakarta, , Indonesia
UN. Mayala
Kuala Lumpur, , Malaysia
National Institute of Oncology
Rabat, , Morocco
University College Hospital
Ibadan, , Nigeria
East Avenue Medical Center
Manila, , Philippines
Jose Reyes
Manila, , Philippines
Philippines General Hospital
Manila, , Philippines
Rizal
Manila, , Philippines
Vicente Sotto Hospital
Manila, , Philippines
Hospital K
Hanoi, , Vietnam
Countries
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References
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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.
Other Identifiers
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OSU-0476
Identifier Type: -
Identifier Source: org_study_id
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