NCT Number: NCT04749446
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
Interested in participating?
Request Info19 year and older
All sexes
Observational
Azienda Ospedaliera S. Orsola-Malpighi, Bologna, BO, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks
To describe treatment that patient diagnosed with breast sarcoma, received
Time frame: Through study inclusion period, an average of 20 years
Number of patient with a diagnosis of primary breast sarcoma
Time frame: Through study inclusion period, an average of 20 years
Number of patients with primary breast sarcoma symptoms
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Time elapsed form the treatment (any) start and the onset of Local-regional relapse
Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
Time elapsed form the treatment (any) start and the onset of progression
Time frame: at 5 years
Time elapsed for the diagnosis to the death for any cause
Time frame: Up to 3 years
To define the median time to secondary sarcoma presentation
Time frame: Up to 3 years
To describe the impact of upfront multidisciplinary tumor board consultation on outcomes
Italian Sarcoma Group
Network
Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes
Acronym: Breast-Sarc
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
