Study on Clinical Features and Outcomes of Breast Sarcoma
ConditionBreast Sarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorItalian Sarcoma Group
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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)
Disqualifiers
sarcoma metastases to the breast
chest wall sarcomas not arising in the mammary gland
cutaneous sarcomas
Trial population
Patients affected by breast sarcma referred to participating Institutions between January 2000 and June 2020.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)
Other interventionThis 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
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Breast sarcoma1 intervention
Trial outcomes
Primary outcomes
1
Treatments received for breast sarcoma
To describe treatment that patient diagnosed with breast sarcoma, received
Time frame
At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks2
Number of patients with primary breast sarcoma
Number of patient with a diagnosis of primary breast sarcoma
Time frame
Through study inclusion period, an average of 20 yearsSecondary outcomes
1
Number of patients with primary breast sarcoma symptoms
Number of patients with primary breast sarcoma symptoms
Time frame
Through study inclusion period, an average of 20 years2
Local-regional Relapse Free Survival (LRFS)
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 years3
Progression Free Survival (PFS)
Time elapsed form the treatment (any) start and the onset of progression
Time frame
Every 3 months (Month 3, Month 6, Month 9...) up to 5 years4
Overall Survival (OS)
Time elapsed for the diagnosis to the death for any cause
Time frame
at 5 yearsSponsors and contacts
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Source ClinicalTrials.gov