ClinicalTrials.gg
RecruitingNCT04749446Breast-SarcUpdated Jan 2, 2026

Study on Clinical Features and Outcomes of Breast Sarcoma

An observational study in Breast Sarcoma, sponsored by Italian Sarcoma Group. Recruiting at 14 sites in Italy. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Italian Sarcoma Group · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
19 Years and older
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Breast Sarcoma
03

In context

Lead sponsor

Italian Sarcoma Group is the lead sponsor of 31 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • sarcoma to the breast
  • chest wall sarcomas not arising in the mammary gland
  • cutaneous sarcomas
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherTreatment 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

06

What researchers measure

Primary outcomes

  1. Treatments received for breast sarcoma

    To describe treatment that patient diagnosed with breast sarcoma, received

    Time frame: At diagnosis (baseline) and after 6, 12, 18, 24, 36, 48 and 60 weeks

  2. Number of patients with primary breast sarcoma

    Number of patient with a diagnosis of primary breast sarcoma

    Time frame: Through study inclusion period, an average of 20 years

Secondary outcomes

  1. Number of patients with primary breast sarcoma symptoms

    Number of patients with primary breast sarcoma symptoms

    Time frame: Through study inclusion period, an average of 20 years

  2. Local-regional Relapse Free Survival (LRFS)

    Time elapsed form the treatment (any) start and the onset of Local-regional relapse

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

  3. Progression Free Survival (PFS)

    Time elapsed form the treatment (any) start and the onset of progression

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

  4. Overall Survival (OS)

    Time elapsed for the diagnosis to the death for any cause

    Time frame: at 5 years

  5. Median time of secondary breast sarcoma presentation

    To define the median time to secondary sarcoma presentation

    Time frame: Up to 3 years

  6. Impact of upfront multidisciplinary tumor board consultation

    To describe the impact of upfront multidisciplinary tumor board consultation on outcomes

    Time frame: Up to 3 years

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Study locations

1 of 14 sites recruiting
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References and documents

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. PubMed 20480227 ↗
  • 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. PubMed 17379448 ↗
  • 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. PubMed 11955733 ↗
  • 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. PubMed 22334455 ↗
  • 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. PubMed 11443624 ↗
  • 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. PubMed 12057135 ↗
  • 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. PubMed 18723152 ↗

Individual participant data

Plan to share: No — Not planned

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2021 (actual). Primary completion is estimated for Dec 2026, 67 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2021
First posted
Feb 11, 2021
StartActual
Apr 2, 2021
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Jan 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04749446
Lead sponsor
Italian Sarcoma Group
Responsible party
Sponsor
First posted
Feb 11, 2021
Start date
Apr 2, 2021
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jan 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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