Study on Clinical Features and Outcomes of Breast Sarcoma

Official title

Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes

Overview

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

• Other Treatment 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

Primary outcome measures

• Treatments received for breast sarcoma [Time frame: At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks]
• Number of patients with primary breast sarcoma [Time frame: Through study inclusion period, an average of 20 years]

Secondary outcome measures (6)

• Number of patients with primary breast sarcoma symptoms [Time frame: Through study inclusion period, an average of 20 years]
• Local-regional Relapse Free Survival (LRFS) [Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years]
• Progression Free Survival (PFS) [Time frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years]
• Overall Survival (OS) [Time frame: at 5 years]
• Median time of secondary breast sarcoma presentation [Time frame: Up to 3 years]
• Impact of upfront multidisciplinary tumor board consultation [Time frame: Up to 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 14 centers

• Azienda Ospedaliera S. Orsola-Malpighi — Bologna
• Istituto Europeo di Oncologia — Milan
• Istituto Clinico Humanitas — Rozzano
• Azienda Ospedaliera Universitaria Paolo Giaccone — Palermo
• Centro di Riferimento Oncologico - Unit of Medical Oncology — Aviano
• Ospedale Misericordia e Dolce — Prato
• Policlinico Universitario Campus Biomedico — Roma
• Fondazione del Piemonte per l'Oncologia IRCC Candiolo — Candiolo
• … and 6 more centers

Publications

• 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. PMID 20480227
• Kirova YM, Gambotti L, De Rycke Y, Vilcoq JR, Asselain B, Fourquet A. Risk of second malignancies after adjuvant radiotherapy for breast cancer: a large-scale, single-institution review. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):359-63. doi: 10.1016/j.ijrobp.2006.12.011. Epub 2007 Mar 26. PMID 17379448
• 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. PMID 11955733
• Sheth GR, Cranmer LD, Smith BD, Grasso-Lebeau L, Lang JE. Radiation-induced sarcoma of the breast: a systematic review. Oncologist. 2012;17(3):405-18. doi: 10.1634/theoncologist.2011-0282. Epub 2012 Feb 14. PMID 22334455
• Huang J, Mackillop WJ. Increased risk of soft tissue sarcoma after radiotherapy in women with breast carcinoma. Cancer. 2001 Jul 1;92(1):172-80. doi: 10.1002/1097-0142(20010701)92:13.0.co;2-k. PMID 11443624
• Trent II JC 2nd, Benjamin RS, Valero V. Primary soft tissue sarcoma of the breast. Curr Treat Options Oncol. 2001 Apr;2(2):169-76. doi: 10.1007/s11864-001-0059-8. PMID 12057135
• 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. PMID 18723152

Identifiers

NCT: NCT04749446 · ISG-Breast-Sarc

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗