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| ID | Type | Description | Link |
|---|---|---|---|
| PROTOCOL BOMET MF14-01 | Other Identifier | TURKISH FEDERATION OF BREAST DISEASE SOCITIES |
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A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.
This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic therapy | Standart chemotherapy |
| |
| Primary surgery | Standart surgery |
| |
| Neoadjuvant chemotherapy | Standart chemotherapy followed by surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Surgery to primary tumor |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Years | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional progression | Number | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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All female patients diagnosed with de novo stage IV breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Atilla Soran, MD, MPH | University of Pittsburgh | Study Chair |
| Serdar Ozbas, MD | Guven Hospital | Principal Investigator |
| Lutfi Doğan, MD | Ankara Onkoloji Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Medical faculty | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D008408 | Mastectomy |
| D015412 | Mastectomy, Segmental |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Systemic therapy | Drug | Systemic therapy based on tumor phenotype |
|
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| D017437 |
| Skin and Connective Tissue Diseases |