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Study on Clinical Features and Outcomes of Breast Sarcoma

Recruiting
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
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)
Read More
Exclusion Criteria
  • sarcoma metastases to the breast
  • chest wall sarcomas not arising in the mammary gland
  • cutaneous sarcomas
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Breast sarcomaTreatment 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
NameTimeMethod
Treatments received for breast sarcomaAt 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 sarcomaThrough study inclusion period, an average of 20 years

Number of patient with a diagnosis of primary breast sarcoma

Secondary Outcome Measures
NameTimeMethod
Number of patients with primary breast sarcoma symptomsThrough study inclusion period, an average of 20 years

Number of patients with primary breast sarcoma symptoms

Impact of upfront multidisciplinary tumor board consultationUp 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 presentationUp to 3 years

To define the median time to secondary sarcoma presentation

Trial Locations

Locations (14)

Azienda Ospedaliera S. Orsola-Malpighi

๐Ÿ‡ฎ๐Ÿ‡น

Bologna, BO, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone

๐Ÿ‡ฎ๐Ÿ‡น

Palermo, PA, Italy

A.O Ospedali Riuniti Marche Nord

๐Ÿ‡ฎ๐Ÿ‡น

Ancona, Italy

ASL Cittร  di Torino (Dipartimento di Oncologia)

๐Ÿ‡ฎ๐Ÿ‡น

Torino, Italy

Ospedale Misericordia e Dolce

๐Ÿ‡ฎ๐Ÿ‡น

Prato, PO, Italy

Policlinico Universitario Campus Biomedico

๐Ÿ‡ฎ๐Ÿ‡น

Roma, RM, Italy

Istituto Europeo di Oncologia

๐Ÿ‡ฎ๐Ÿ‡น

Milano, MI, Italy

Centro di Riferimento Oncologico - Unit of Medical Oncology

๐Ÿ‡ฎ๐Ÿ‡น

Aviano, Pordenone, Italy

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

๐Ÿ‡ฎ๐Ÿ‡น

Roma, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

๐Ÿ‡ฎ๐Ÿ‡น

Candiolo, Torino, Italy

Ospedale Umberto I

๐Ÿ‡ฎ๐Ÿ‡น

Turin, TO, Italy

Istituto Clinico Humanitas

๐Ÿ‡ฎ๐Ÿ‡น

Rozzano, MI, Italy

Azienda Ospedaliera Universitaria Careggi

๐Ÿ‡ฎ๐Ÿ‡น

Firenze, Italy

Fondazione IRCCS INT Milano

๐Ÿ‡ฎ๐Ÿ‡น

Milano, Italy

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