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Study on Clinical Features and Outcomes of Breast Sarcoma

Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04749446
Acronym
Breast-Sarc
Enrollment
300
Registered
2021-02-11
Start date
2021-04-02
Completion date
2026-12-01
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Sarcoma

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.

Interventions

OTHERTreatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)

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

Sponsors

Italian Sarcoma Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatments received for breast sarcomaAt diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeksTo describe treatment that patient diagnosed with breast sarcoma, received
Number of patients with primary breast sarcomaThrough study inclusion period, an average of 20 yearsNumber of patient with a diagnosis of primary breast sarcoma

Secondary

MeasureTime frameDescription
Progression Free Survival (PFS)Every 3 months (Month 3, Month 6, Month 9...) up to 5 yearsTime elapsed form the treatment (any) start and the onset of progression
Overall Survival (OS)at 5 yearsTime elapsed for the diagnosis to the death for any cause
Number of patients with primary breast sarcoma symptomsThrough study inclusion period, an average of 20 yearsNumber of patients with primary breast sarcoma symptoms
Impact of upfront multidisciplinary tumor board consultationUp to 3 yearsTo describe the impact of upfront multidisciplinary tumor board consultation on outcomes
Median time of secondary breast sarcoma presentationUp to 3 yearsTo define the median time to secondary sarcoma presentation
Local-regional Relapse Free Survival (LRFS)Every 3 months (Month 3, Month 6, Month 9...) up to 5 yearsTime elapsed form the treatment (any) start and the onset of Local-regional relapse

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026