Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes
| Registry | NCT04749446, acronym Breast-Sarc |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 300 (Estimated) |
| Sponsor | Italian Sarcoma Group (Network) |
| Conditions | Breast Sarcoma |
| Interventions | Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments) (Other) |
| Dates | start 2021-04-02, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2021-02-11, last updated 2026-01-02 |
| Locations | 14 sites in Italy |
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All trials for Breast Sarcoma All trials of Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Breast sarcoma | Other: 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. |
Sex: All, ages: 19 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Azienda Ospedaliera S. Orsola-Malpighi | Bologna, BO | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia | Milan, MI | Italy | Not yet recruiting |
| Istituto Clinico Humanitas | Rozzano, MI | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Paolo Giaccone | Palermo, PA | Italy | Not yet recruiting |
| Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano, Pordenone | Italy | Not yet recruiting |
| Ospedale Misericordia e Dolce | Prato, PO | Italy | Not yet recruiting |
| Policlinico Universitario Campus Biomedico | Roma, RM | Italy | Not yet recruiting |
| Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo, Torino | Italy | Recruiting |
| Ospedale Umberto I | Turin, TO | Italy | Not yet recruiting |
| A.O Ospedali Riuniti Marche Nord | Ancona | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy | Not yet recruiting |
| Fondazione IRCCS INT Milano | Milan | Italy | Not yet recruiting |
| Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | Roma | Italy | Not yet recruiting |
| ASL Città di Torino (Dipartimento di Oncologia) | Torino | Italy | Not yet recruiting |