Clinical trial NCT04749446: Study on Clinical Features and Outcomes of Breast Sarcoma
Official title: Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Sarcoma
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2021-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by breast sarcma referred to participating Institutions between January 2000 and June 2020.

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.

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

Primary outcomes:
measure: Treatments received for breast sarcoma
timeFrame: At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks
measure: Number of patients with primary breast sarcoma
timeFrame: Through study inclusion period, an average of 20 years
Secondary outcomes:
measure: Number of patients with primary breast sarcoma symptoms
timeFrame: Through study inclusion period, an average of 20 years
measure: Local-regional Relapse Free Survival (LRFS)
timeFrame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
measure: Progression Free Survival (PFS)
timeFrame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years
measure: Overall Survival (OS)
timeFrame: at 5 years
measure: Median time of secondary breast sarcoma presentation
timeFrame: Up to 3 years
measure: Impact of upfront multidisciplinary tumor board consultation
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliera S. Orsola-Malpighi
state: BO
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone
state: PA
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Unit of Medical Oncology
state: Pordenone
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce
state: PO
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
state: RM
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo
state: Torino
city: Turin
country: Italy
facility: Ospedale Umberto I
state: TO
city: Ancona
country: Italy
facility: A.O Ospedali Riuniti Marche Nord
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: Fondazione IRCCS INT Milano
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
city: Torino
country: Italy
facility: ASL Città di Torino (Dipartimento di Oncologia)
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.