Study on Clinical Features and Outcomes of Breast Sarcoma (Breast-Sarc)

Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes

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

Study Overview

• Status: Recruiting
• Conditions: Breast Sarcoma
• Intervention / Treatment: Other: Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Not yet recruiting
    • A.O Ospedali Riuniti Marche Nord
    • Contact: Raffaella Bracci, MD; Phone Number: 11 039 0721 36; Email: raffaella.bracci@ospedalimarchenord.it
    • Principal Investigator: Raffaella Bracci, MD
  • Florence, Italy, 50100
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Careggi
    • Contact: Silvia Gasperoni, MD; Phone Number: 39 055 7949648; Email: gasperoni.silvia@gmail.com
    • Principal Investigator: Silvia Gasperoni, MD
  • Milan, Italy, 20133
    • Not yet recruiting
    • Fondazione IRCCS INT Milano
    • Contact: Silvia Stacchiotti, MD; Phone Number: 2804 +39022390; Email: silvia.stacchiotti@istitutotumori.mi.it
    • Principal Investigator: Silvia Stacchiotti, MD
  • Roma, Italy, 00144
    • Not yet recruiting
    • Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
    • Contact: MD
    • Principal Investigator: Virginia Ferraresi, MD
    • Contact: Virginia Ferraresi, MD; Phone Number: 773 +390652666; Email: ferraresi@ifo.it
  • Torino, Italy, 10153
    • Not yet recruiting
    • ASL Città di Torino (Dipartimento di Oncologia)
    • Contact: Antonella Boglione, MD; Email: antonella.boglione@aslcittaditorino.it
    • Contact: Boglione, MD
    • Principal Investigator: Antonella Boglione, MD
  • BO
    • Bologna, BO, Italy, 40138
      • Not yet recruiting
      • Azienda Ospedaliera S. Orsola-Malpighi
      • Contact: Maria Abbondanza Pantaleo, MD; Phone Number: +39 051 2144043; Email: maria.pantaleo@unibo.it
      • Principal Investigator: Maria Abbondanza Pantaleo, MD
  • MI
    • Milan, MI, Italy, 20141
      • Not yet recruiting
      • Istituto Europeo di Oncologia
      • Principal Investigator: Tommaso M. De Pas, MD
      • Contact: Tommaso M. De Pas, MD; Phone Number: +390257489482; Email: tommaso.de-pas@ieo.it
    • Rozzano, MI, Italy, 20089
      • Not yet recruiting
      • Istituto Clinico Humanitas
      • Contact: Alexia Bertuzzi, MD; Phone Number: +390282244540; Email: alexia.bertuzzi@cancercenter.humanitas.it
      • Principal Investigator: Alexia Bertuzzi, MD
  • PA
    • Palermo, PA, Italy, 90127
      • Not yet recruiting
      • Azienda Ospedaliera Universitaria Paolo Giaccone
      • Contact: Giuseppe Badalamenti, MD; Phone Number: 4513 0039091655; Email: giuseppebadalamenti@unipa.it
      • Contact: Badalamenti
      • Principal Investigator: Giuseppe Badalamenti, MD
  • PO
    • Prato, PO, Italy, 59100
      • Not yet recruiting
      • Ospedale Misericordia e Dolce
      • Contact: Giacomo G. Baldi, MD; Email: ggbaldi@usl4.toscana.it
      • Principal Investigator: Giacomo G. Baldi, MD
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Not yet recruiting
      • Centro di Riferimento Oncologico - Unit of Medical Oncology
      • Contact: Angela Buonadonna, MD; Email: abuonadonna@cro.it
      • Contact: Angela, MD
      • Sub-Investigator: Angela Buonadonna, MD
  • RM
    • Roma, RM, Italy, 00128
      • Not yet recruiting
      • Policlinico Universitario Campus Biomedico
      • Principal Investigator: Bruno Vincenzi, MD
      • Contact: Bruno Vincenzi, MD; Phone Number: +3902225411123; Email: b.vincenzi@unicampus.it
  • TO
    • Turin, TO, Italy
      • Not yet recruiting
      • Ospedale Umberto I
      • Contact: Nicoletta Biglia; Phone Number: 682 039 0115082; Email: nicoletta.biglia@unito.it
      • Principal Investigator: Nicoletta Biglia
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Recruiting
      • Fondazione del Piemonte per l'Oncologia IRCC Candiolo
      • Contact: Giovanni Grignani, MD; Phone Number: 3623 39 (011) 993; Email: giovanni.grignani@ircc.it
      • Principal Investigator: Giovanni Grignani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by breast sarcma referred to participating Institutions between January 2000 and June 2020.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast sarcoma; This cohort include patients affected by breast sarcoma, referred to participating Institutions between January 2000 and June 2020.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time elapsed for the diagnosis to the death for any cause	at 5 years
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
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
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
Median time of secondary breast sarcoma presentation	To define the median time to secondary sarcoma presentation	Up to 3 years
Impact of upfront multidisciplinary tumor board consultation	To describe the impact of upfront multidisciplinary tumor board consultation on outcomes	Up to 3 years

Collaborators and Investigators

• Sponsor: Italian Sarcoma Group

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Surgical Procedures, Operative
• Other Study ID Numbers: ISG-Breast-Sarc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No