Study on Clinical Features and Outcomes of Breast Sarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-02

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Breast Sarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast sarcoma

This cohort include patients affected by breast sarcoma, referred to participating Institutions between January 2000 and June 2020.

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

Intervention Type 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

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Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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ISG-Breast-Sarc

Identifier Type: -

Identifier Source: org_study_id

Study on Clinical Features and Outcomes of Breast Sarcoma

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Breast sarcoma

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)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Italian Sarcoma Group

Responsible Party

Locations

Azienda Ospedaliera S. Orsola-Malpighi

Istituto Europeo di Oncologia

Istituto Clinico Humanitas

Azienda Ospedaliera Universitaria Paolo Giaccone

Centro di Riferimento Oncologico - Unit of Medical Oncology

Ospedale Misericordia e Dolce

Policlinico Universitario Campus Biomedico

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Ospedale Umberto I

A.O Ospedali Riuniti Marche Nord

Azienda Ospedaliera Universitaria Careggi

Fondazione IRCCS INT Milano

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

ASL Città di Torino (Dipartimento di Oncologia)

Countries

Facility Contacts

Maria Abbondanza Pantaleo, MD

Tommaso M. De Pas, MD

Alexia Bertuzzi, MD

Giuseppe Badalamenti, MD

Badalamenti

Angela Buonadonna, MD

Angela, MD

Giacomo G. Baldi, MD

Bruno Vincenzi, MD

Giovanni Grignani, MD

Nicoletta Biglia

Raffaella Bracci, MD

Silvia Gasperoni, MD

Silvia Stacchiotti, MD

Virginia Ferraresi, MD

MD

Antonella Boglione, MD

Boglione, MD

References

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.

Other Identifiers

ISG-Breast-Sarc