Study on Clinical Features and Outcomes of Breast Sarcoma

NCT04749446 | Recruiting

• 1 other identifier: ISG-Breast-Sarc
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 14

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

Conditions

Breast Sarcoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Number of patients with primary breast sarcoma symptoms

  Through study inclusion period, an average of 20 years

• Local-regional Relapse Free Survival (LRFS)

  Every 3 months (Month 3, Month 6, Month 9...) up to 5 years

• Progression Free Survival (PFS)

  Every 3 months (Month 3, Month 6, Month 9...) up to 5 years

• Overall Survival (OS)

  at 5 years

• Median time of secondary breast sarcoma presentation

  Up to 3 years

Study Arms (1)

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)

Interventions

Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments) OTHER

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

Breast sarcoma

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>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)

You may not qualify if:

• sarcoma metastases to the breast
• chest wall sarcomas not arising in the mammary gland
• cutaneous sarcomas

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (14)

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, BO, 40138, Italy

NOT YET RECRUITING

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, 90127, Italy

NOT YET RECRUITING

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, 33081, Italy

NOT YET RECRUITING

Ospedale Misericordia e Dolce

Prato, PO, 59100, Italy

NOT YET RECRUITING

Policlinico Universitario Campus Biomedico

Roma, RM, 00128, Italy

NOT YET RECRUITING

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, 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, 50100, Italy

NOT YET RECRUITING

Fondazione IRCCS INT Milano

Milan, 20133, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

Roma, 00144, Italy

NOT YET RECRUITING

ASL Città di Torino (Dipartimento di Oncologia)

Torino, 10153, Italy

NOT YET RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 11, 2021
• Study Start: April 2, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (14)