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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen |
|
| B | Active Comparator | Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oophorectomy | Procedure | Excision of an ovary |
| |
| Tamoxifen |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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. | Up to 9 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard R. Love, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States | ||
| Dhaka Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27107325 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A Mid-luteal Surgery | |
| FG001 | B Mid-follicular Surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
20 mg orally every day |
|
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| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A Mid-luteal Surgery | |
| BG001 | B Mid-follicular Surgery | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Dominant metastatic site | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | 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. | Analyzed all patients with followup data | Posted | Median | 95% Confidence Interval | years | Up to 9 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Mid-luteal Surgery | 0 | 115 | 0 | 115 | |||
| EG001 | B Mid-follicular Surgery | 1 | 119 | 0 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment | Pt developed deep vein thrombosis and was successfully treated with anti-coagulants. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard R. Love, MD | International Breast Cancer Research Foundation | 608-698-7881 | richardibcrf@gmail.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010052 | Ovariectomy |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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| Bangladesh |
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| Morocco |
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| Philippines |
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| China |
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| Malaysia |
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| Nigeria |
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| Indonesia |
|
| Taiwan |
|
| Bone |
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| Viscera |
|