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This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate surgery | Active Comparator | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen |
|
| Scheduled surgery | Experimental | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen |
|
| Immediate Surgery - nonrandomized | Other | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 20 mg po daily x 5 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | 5-year disease-free survival | two- to three-year accrual and initial two or more years of follow-up period |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard R. Love, M.D. | International Breast Cancer Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Oncology | Rabat | Morocco | ||||
| Vicente Soto Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31443726 | Derived | Hade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Scheduled Surgery | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Surgery: Oophorectomy | Procedure | Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
|
|
| Cebu |
| Philippines |
| East Avenue Medical Center | Manila | Philippines |
| Philippine General Hospital | Manila | Philippines |
| Rizal | Manila | Philippines |
| Santo Toma Hospital | Manila | Philippines |
| Danang General | Da Nang | Vietnam |
| Hospital K, National Cancer Institute | Hanoi | Vietnam |
| Hue Central | Huế | Vietnam |
| FG001 | B - Immediate Surgery | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
| FG002 | C- Immediate Surgery - Nonrandomized | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline measures were not available on all participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | A - Scheduled Surgery | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
| BG001 | B - Immediate Surgery | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
| BG002 | C- Immediate Surgery - Nonrandomized | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) |
| BG003 | 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 |
| ||||||||||||||||
| Estrogen receptor status | Number | participants |
| ||||||||||||||||
| Progesterone receptor status | Number | participants |
| ||||||||||||||||
| HER2/Neu status | Number | participants |
| ||||||||||||||||
| Number of positive axillary nodes | Number | participants |
| ||||||||||||||||
| Pathologic tumor size | Mean | Standard Deviation | cm |
| |||||||||||||||
| Progesterone level on day of surgery (ng/ml) | Number | participants |
|
| 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 | Disease-free Survival | 5-year disease-free survival | Posted | Number | percentage of participants | two- to three-year accrual and initial two or more years of follow-up period |
|
|
|
Over entire course of study
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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 - Scheduled Surgery | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | 0 | 244 | 0 | 244 | ||
| EG001 | B - Immediate Surgery | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | 5 | 255 | 0 | 255 | ||
| EG002 | C- Immediate Surgery - Nonrandomized | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization Tamoxifen: 20 mg po daily x 5 years Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c) | 1 | 230 | 0 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Endocervical cancer | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Venous thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Nosocomial pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard R. Love | International Breast Cancer Research Foundation | 608-698-7881 | richardibcrf@gmail.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D010052 | Ovariectomy |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
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| Male |
|
| Negative |
|
| Negative |
|
| Negative |
|
| 1-3 |
|
| 4+ |
|
| 2-4.99 |
|
| 5+ |
|