Breast Sarcoma Clinical Trial
— Breast-SarcOfficial title:
Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes
| Verified date | October 2023 |
| Source | Italian Sarcoma Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 1, 2023 |
| Est. primary completion date | December 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | A.O Ospedali Riuniti Marche Nord | Ancona | |
| Italy | Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano | Pordenone |
| Italy | Azienda Ospedaliera S. Orsola-Malpighi | Bologna | BO |
| Italy | Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo | Torino |
| Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
| Italy | Fondazione IRCCS INT Milano | Milano | |
| Italy | Istituto Europeo di Oncologia | Milano | MI |
| Italy | Azienda Ospedaliera Universitaria Paolo Giaccone | Palermo | PA |
| Italy | Ospedale Misericordia e Dolce | Prato | PO |
| Italy | Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | Roma | |
| Italy | Policlinico Universitario Campus Biomedico | Roma | RM |
| Italy | Istituto Clinico Humanitas | Rozzano | MI |
| Italy | ASL Città di Torino (Dipartimento di Oncologia) | Torino | |
| Italy | Ospedale Umberto I | Turin | TO |
| Lead Sponsor | Collaborator |
|---|---|
| Italian Sarcoma Group |
Italy,
Al-Benna S, Poggemann K, Steinau HU, Steinstraesser L. Diagnosis and management of primary breast sarcoma. Breast Cancer Res Treat. 2010 Aug;122(3):619-26. doi: 10.1007/s10549-010-0915-y. Epub 2010 May 18. — View Citation
Fields RC, Aft RL, Gillanders WE, Eberlein TJ, Margenthaler JA. Treatment and outcomes of patients with primary breast sarcoma. Am J Surg. 2008 Oct;196(4):559-61. doi: 10.1016/j.amjsurg.2008.06.010. Epub 2008 Aug 23. — View Citation
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Yap J, Chuba PJ, Thomas R, Aref A, Lucas D, Severson RK, Hamre M. Sarcoma as a second malignancy after treatment for breast cancer. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1231-7. doi: 10.1016/s0360-3016(01)02799-7. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatments received for breast sarcoma | To describe treatment that patient diagnosed with breast sarcoma, received | At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks | |
| Primary | Number of patients with primary breast sarcoma | Number of patient with a diagnosis of primary breast sarcoma | Through study inclusion period, an average of 20 years | |
| Secondary | Number of patients with primary breast sarcoma symptoms | Number of patients with primary breast sarcoma symptoms | Through study inclusion period, an average of 20 years | |
| Secondary | Local-regional Relapse Free Survival (LRFS) | Time elapsed form the treatment (any) start and the onset of Local-regional relapse | Every 3 months (Month 3, Month 6, Month 9...) up to 5 years | |
| Secondary | Progression Free Survival (PFS) | Time elapsed form the treatment (any) start and the onset of progression | Every 3 months (Month 3, Month 6, Month 9...) up to 5 years | |
| Secondary | Overall Survival (OS) | Time elapsed for the diagnosis to the death for any cause | at 5 years | |
| Secondary | Median time of secondary breast sarcoma presentation | To define the median time to secondary sarcoma presentation | Up to 3 years | |
| Secondary | Impact of upfront multidisciplinary tumor board consultation | To describe the impact of upfront multidisciplinary tumor board consultation on outcomes | Up to 3 years |