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This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | Undergo SBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of stereotactic body radiotherapy (SBRT) | the dose of radiotherapy associated with a ≤ 20% rate pre-specified treatment-related dose -limiting toxicity (DLT) occurring within 6 months from the start of treatment. DLT is defined as any grade 3 or worse toxicity according to CTCAE v.4 related to the following specific symptoms:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of long-term adverse events | scored according to the NCI CTCAE v. 4.2 | 2 years |
| Breast Cosmesis | scored according to the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer for the evaluation of cosmetics (score 1 to 4, no difference-large difference by comparing the treated breast to the controlateral breast) and carried out separately by the doctor and the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Primary breast tumor local failure | 2 years local failure probability of treated primary tumor predicted by CT planning images | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edy Ippolito, MD | Contact | +3906225418011 | e.ippolito@unicampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Campus Biomedico | Recruiting | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37007063 | Derived | Ippolito E, Silipigni S, Pantano F, Matteucci P, Carrafiello S, Marrocco M, Alaimo R, Palumbo V, Fiore M, Orsaria P, D'Angelillo RM, Altomare V, Tonini G, Ramella S. BOMB trial: First results of stereotactic radiotherapy to primary breast tumor in metastatic breast cancer patients. Front Oncol. 2023 Mar 17;13:1062355. doi: 10.3389/fonc.2023.1062355. eCollection 2023. |
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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 |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 2 years |
| QoL | scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23) | 2 years |
| Primary breast tumor best response | evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |