Study on Clinical Features and Outcomes of Breast Sarcoma
- Conditions
- Breast Sarcoma
- Interventions
- Other: Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)
- Registration Number
- NCT04749446
- Lead Sponsor
- Italian Sarcoma Group
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- >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)
- sarcoma metastases to the breast
- chest wall sarcomas not arising in the mammary gland
- cutaneous sarcomas
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Breast sarcoma Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments) This cohort include patients affected by breast sarcoma, referred to participating Institutions between January 2000 and June 2020.
- Primary Outcome Measures
Name Time Method Treatments received for breast sarcoma At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks To describe treatment that patient diagnosed with breast sarcoma, received
Number of patients with primary breast sarcoma Through study inclusion period, an average of 20 years Number of patient with a diagnosis of primary breast sarcoma
- Secondary Outcome Measures
Name Time Method Number of patients with primary breast sarcoma symptoms Through study inclusion period, an average of 20 years Number of patients with primary breast sarcoma symptoms
Impact of upfront multidisciplinary tumor board consultation Up to 3 years To describe the impact of upfront multidisciplinary tumor board consultation on outcomes
Local-regional Relapse Free Survival (LRFS) 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
Progression Free Survival (PFS) 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
Overall Survival (OS) at 5 years Time elapsed for the diagnosis to the death for any cause
Median time of secondary breast sarcoma presentation Up to 3 years To define the median time to secondary sarcoma presentation
Trial Locations
- Locations (14)
Azienda Ospedaliera S. Orsola-Malpighi
๐ฎ๐นBologna, BO, Italy
Azienda Ospedaliera Universitaria Paolo Giaccone
๐ฎ๐นPalermo, PA, Italy
A.O Ospedali Riuniti Marche Nord
๐ฎ๐นAncona, Italy
ASL Cittร di Torino (Dipartimento di Oncologia)
๐ฎ๐นTorino, Italy
Ospedale Misericordia e Dolce
๐ฎ๐นPrato, PO, Italy
Policlinico Universitario Campus Biomedico
๐ฎ๐นRoma, RM, Italy
Istituto Europeo di Oncologia
๐ฎ๐นMilano, MI, Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology
๐ฎ๐นAviano, Pordenone, Italy
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
๐ฎ๐นRoma, Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
๐ฎ๐นCandiolo, Torino, Italy
Ospedale Umberto I
๐ฎ๐นTurin, TO, Italy
Istituto Clinico Humanitas
๐ฎ๐นRozzano, MI, Italy
Azienda Ospedaliera Universitaria Careggi
๐ฎ๐นFirenze, Italy
Fondazione IRCCS INT Milano
๐ฎ๐นMilano, Italy