Study on Clinical Features and Outcomes of Breast Sarcoma

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes

Conditions
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Breast Sarcoma

Intervention / Treatment
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* Other: Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years at diagnosis primary or secondary breast sarcoma availability of medical data needed for the study (histopathological data, surgery, chemotherapy, including preceding chemotherapeutic regimens for secondary breast sarcomas, radiation therapy) Exclusion Criteria: sarcoma metastases to the breast chest wall sarcomas not arising in the mammary gland cutaneous sarcomas

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast sarcoma<br>This cohort include patients affected by breast sarcoma, referred to participating Institutions between January 2000 and June 2020. | Other: Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |