Study on Clinical Features and Outcomes of Breast Sarcoma

Recruiting

• Conditions: Breast Sarcoma

• 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.

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Study Start: 2021-04-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

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)

Exclusion Criteria

• 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

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; 🇮🇹 Bologna, BO, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milano, MI, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone; 🇮🇹 Palermo, PA, Italy

Centro di Riferimento Oncologico - Unit of Medical Oncology; 🇮🇹 Aviano, Pordenone, Italy

Ospedale Misericordia e Dolce; 🇮🇹 Prato, PO, Italy

Policlinico Universitario Campus Biomedico; 🇮🇹 Roma, RM, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo; 🇮🇹 Candiolo, Torino, Italy

Ospedale Umberto I; 🇮🇹 Turin, TO, Italy

A.O Ospedali Riuniti Marche Nord; 🇮🇹 Ancona, Italy

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