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This is multi-institutional retrospective study in order to identify the most relevant clinical characteristics, treatment strategies, to explore the impact on principal clinical outcomes and finally, to suggest some principles for management and treatment of breast sarcomas.
The study will collect data about patients affected by breast sarcoma referred to participating Institutions between January 2000 and June 2020
In the field of soft tissue sarcomas, breast sarcomas are a truly peculiar family of rare tumors for both their clinical history and biology of disease.
Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological (chemotherapeutic) and/or radiotherapeutic treatment is reserved to those with high-risk/recurrent-relapsing/metastatic disease.
Unfortunately, there is a lack of specific prospective trials in breast sarcoma to guide the clinical decision-making and breast sarcoma patients are often sent to sarcoma referral centers only after surgery Due to sarcoma-specific clinical features, it is clear that both diagnostic and clinical strategies mandate a different approach compared to epithelial tumors. This is of key importance to reach the correct diagnosis, design the best therapeutic decision-making and subsequent follow-up.
Even if retrospective data limitations and biases, in the lack of prospective data collection, these data may be a unique and precious source of information For this reasons this multi-institutional retrospective study is aimed to identify the most relevant clinical characteristics, treatment strategies, to explore the impact on principal clinical outcomes and finally, to suggest some principles for management and treatment of breast sarcomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast sarcoma | This cohort include patients affected by breast sarcoma, referred to participating Institutions between January 2000 and June 2020. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments) | Other | This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments Reorder Outcome Measures |
| Measure | Description | Time Frame |
|---|---|---|
| Treatments received for breast sarcoma | To describe treatment that patient diagnosed with breast sarcoma, received | At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks |
| Number of patients with primary breast sarcoma | Number of patient with a diagnosis of primary breast sarcoma | Through study inclusion period, an average of 20 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with primary breast sarcoma symptoms | Number of patients with primary breast sarcoma symptoms | Through study inclusion period, an average of 20 years |
| Local-regional Relapse Free Survival (LRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients affected by breast sarcma referred to participating Institutions between January 2000 and June 2020.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera S. Orsola-Malpighi | Not yet recruiting | Bologna | BO | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20480227 | Background | Al-Benna S, Poggemann K, Steinau HU, Steinstraesser L. Diagnosis and management of primary breast sarcoma. Breast Cancer Res Treat. 2010 Aug;122(3):619-26. doi: 10.1007/s10549-010-0915-y. Epub 2010 May 18. | |
| 17379448 | Background | Kirova YM, Gambotti L, De Rycke Y, Vilcoq JR, Asselain B, Fourquet A. Risk of second malignancies after adjuvant radiotherapy for breast cancer: a large-scale, single-institution review. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):359-63. doi: 10.1016/j.ijrobp.2006.12.011. Epub 2007 Mar 26. |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
Time elapsed form the treatment (any) start and the onset of Local-regional relapse
| Every 3 months (Month 3, Month 6, Month 9...) up to 5 years |
| Progression Free Survival (PFS) | Time elapsed form the treatment (any) start and the onset of progression | Every 3 months (Month 3, Month 6, Month 9...) up to 5 years |
| Overall Survival (OS) | Time elapsed for the diagnosis to the death for any cause | at 5 years |
| Median time of secondary breast sarcoma presentation | To define the median time to secondary sarcoma presentation | Up to 3 years |
| Impact of upfront multidisciplinary tumor board consultation | To describe the impact of upfront multidisciplinary tumor board consultation on outcomes | Up to 3 years |
| Istituto Europeo di Oncologia | Not yet recruiting | Milan | MI | 20141 | Italy |
|
| Istituto Clinico Humanitas | Not yet recruiting | Rozzano | MI | 20089 | Italy |
|
| Azienda Ospedaliera Universitaria Paolo Giaccone | Not yet recruiting | Palermo | PA | 90127 | Italy |
|
| Centro di Riferimento Oncologico - Unit of Medical Oncology | Not yet recruiting | Aviano | Pordenone | 33081 | Italy |
|
| Ospedale Misericordia e Dolce | Not yet recruiting | Prato | PO | 59100 | Italy |
|
| Policlinico Universitario Campus Biomedico | Not yet recruiting | Roma | RM | 00128 | Italy |
|
| Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Recruiting | Candiolo | Torino | 10060 | Italy |
|
| Ospedale Umberto I | Not yet recruiting | Turin | TO | Italy |
|
| A.O Ospedali Riuniti Marche Nord | Not yet recruiting | Ancona | Italy |
|
| Azienda Ospedaliera Universitaria Careggi | Not yet recruiting | Florence | 50100 | Italy |
|
| Fondazione IRCCS INT Milano | Not yet recruiting | Milan | 20133 | Italy |
|
| Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | Not yet recruiting | Roma | 00144 | Italy |
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| ASL Città di Torino (Dipartimento di Oncologia) | Not yet recruiting | Torino | 10153 | Italy |
|
| 11955733 | Background | Yap J, Chuba PJ, Thomas R, Aref A, Lucas D, Severson RK, Hamre M. Sarcoma as a second malignancy after treatment for breast cancer. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1231-7. doi: 10.1016/s0360-3016(01)02799-7. |
| 22334455 | Background | Sheth GR, Cranmer LD, Smith BD, Grasso-Lebeau L, Lang JE. Radiation-induced sarcoma of the breast: a systematic review. Oncologist. 2012;17(3):405-18. doi: 10.1634/theoncologist.2011-0282. Epub 2012 Feb 14. |
| 11443624 | Background | Huang J, Mackillop WJ. Increased risk of soft tissue sarcoma after radiotherapy in women with breast carcinoma. Cancer. 2001 Jul 1;92(1):172-80. doi: 10.1002/1097-0142(20010701)92:13.0.co;2-k. |
| 12057135 | Background | Trent II JC 2nd, Benjamin RS, Valero V. Primary soft tissue sarcoma of the breast. Curr Treat Options Oncol. 2001 Apr;2(2):169-76. doi: 10.1007/s11864-001-0059-8. |
| 18723152 | Background | Fields RC, Aft RL, Gillanders WE, Eberlein TJ, Margenthaler JA. Treatment and outcomes of patients with primary breast sarcoma. Am J Surg. 2008 Oct;196(4):559-61. doi: 10.1016/j.amjsurg.2008.06.010. Epub 2008 Aug 23. |