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

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ClinicalTrials.gov Identifier: NCT04749446
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

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


Condition or disease Intervention/treatment
Breast Sarcoma 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Breast Sarcomas: A Retrospective Analysis of Clinical Features and Outcomes
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. Treatments received for breast sarcoma [ Time Frame: At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks ]
    To describe treatment that patient diagnosed with breast sarcoma, received

  2. Number of patients with primary breast sarcoma [ Time Frame: Through study inclusion period, an average of 20 years ]
    Number of patient with a diagnosis of primary breast sarcoma


Secondary Outcome Measures :
  1. Number of patients with primary breast sarcoma symptoms [ Time Frame: Through study inclusion period, an average of 20 years ]
    Number of patients with primary breast sarcoma symptoms

  2. Local-regional Relapse Free Survival (LRFS) [ Time Frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years ]
    Time elapsed form the treatment (any) start and the onset of Local-regional relapse

  3. Progression Free Survival (PFS) [ Time Frame: Every 3 months (Month 3, Month 6, Month 9...) up to 5 years ]
    Time elapsed form the treatment (any) start and the onset of progression

  4. Overall Survival (OS) [ Time Frame: at 5 years ]
    Time elapsed for the diagnosis to the death for any cause

  5. Median time of secondary breast sarcoma presentation [ Time Frame: Up to 3 years ]
    To define the median time to secondary sarcoma presentation

  6. Impact of upfront multidisciplinary tumor board consultation [ Time Frame: Up to 3 years ]
    To describe the impact of upfront multidisciplinary tumor board consultation on outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749446


Locations
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Italy
Azienda Ospedaliera S. Orsola-Malpighi Not yet recruiting
Bologna, BO, Italy, 40138
Contact: Maria Abbondanza Pantaleo, MD    +39 051 2144043    maria.pantaleo@unibo.it   
Principal Investigator: Maria Abbondanza Pantaleo, MD         
Istituto Europeo di Oncologia Not yet recruiting
Milano, MI, Italy, 20141
Contact: Tommaso M. De Pas, MD    +390257489482    tommaso.de-pas@ieo.it   
Principal Investigator: Tommaso M. De Pas, MD         
Istituto Clinico Humanitas Not yet recruiting
Rozzano, MI, Italy, 20089
Contact: Alexia Bertuzzi, MD    +390282244540    alexia.bertuzzi@cancercenter.humanitas.it   
Principal Investigator: Alexia Bertuzzi, MD         
Azienda Ospedaliera Universitaria Paolo Giaccone Not yet recruiting
Palermo, PA, Italy, 90127
Contact: Giuseppe Badalamenti, MD    0039091655 ext 4513    giuseppebadalamenti@unipa.it   
Contact: Badalamenti         
Principal Investigator: Giuseppe Badalamenti, MD         
Centro di Riferimento Oncologico - Unit of Medical Oncology Not yet recruiting
Aviano, Pordenone, Italy, 33081
Contact: Angela Buonadonna, MD       abuonadonna@cro.it   
Contact: Angela, MD         
Sub-Investigator: Angela Buonadonna, MD         
Ospedale Misericordia e Dolce Not yet recruiting
Prato, PO, Italy, 59100
Contact: Giacomo G. Baldi, MD       ggbaldi@usl4.toscana.it   
Principal Investigator: Giacomo G. Baldi, MD         
Policlinico Universitario Campus Biomedico Not yet recruiting
Roma, RM, Italy, 00128
Contact: Bruno Vincenzi, MD    +3902225411123    b.vincenzi@unicampus.it   
Principal Investigator: Bruno Vincenzi, MD         
Fondazione del Piemonte per l'Oncologia IRCC Candiolo Recruiting
Candiolo, Torino, Italy, 10060
Contact: Giovanni Grignani, MD    39 (011) 993 ext 3623    giovanni.grignani@ircc.it   
Principal Investigator: Giovanni Grignani, MD         
Ospedale Umberto I Not yet recruiting
Turin, TO, Italy
Contact: Nicoletta Biglia    039 0115082 ext 682    nicoletta.biglia@unito.it   
Principal Investigator: Nicoletta Biglia         
A.O Ospedali Riuniti Marche Nord Not yet recruiting
Ancona, Italy
Contact: Raffaella Bracci, MD    039 0721 36 ext 11    raffaella.bracci@ospedalimarchenord.it   
Principal Investigator: Raffaella Bracci, MD         
Azienda Ospedaliera Universitaria Careggi Not yet recruiting
Firenze, Italy, 50100
Contact: Silvia Gasperoni, MD    39 055 7949648    gasperoni.silvia@gmail.com   
Principal Investigator: Silvia Gasperoni, MD         
Fondazione IRCCS INT Milano Not yet recruiting
Milano, Italy, 20133
Contact: Silvia Stacchiotti, MD    +39022390 ext 2804    silvia.stacchiotti@istitutotumori.mi.it   
Principal Investigator: Silvia Stacchiotti, MD         
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I Not yet recruiting
Roma, Italy, 00144
Contact: Virginia Ferraresi, MD    +390652666 ext 773    ferraresi@ifo.it   
Contact: MD         
Principal Investigator: Virginia Ferraresi, MD         
ASL Città di Torino (Dipartimento di Oncologia) Not yet recruiting
Torino, Italy, 10153
Contact: Antonella Boglione, MD       antonella.boglione@aslcittaditorino.it   
Contact: Boglione, MD         
Principal Investigator: Antonella Boglione, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Publications:
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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT04749446    
Other Study ID Numbers: ISG-Breast-Sarc
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms