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RecruitingNot ApplicableNCT05673304

Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer

Immune and Pathological Response in Breast Cancer After Preoperative Irradiation With Stereotactic Technique and Neoadjuvant ChemOtherapy

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

30 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Breast CancerRadiotherapy

Summary

IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pathological complete response (pCR) in Luminal B breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an anticipated boost associated with neoadjuvant chemotherapy (NAC). As a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Luminal B-like BC, cT1-2
  • Indication for neoadjuvant chemotherapy

Exclusion Criteria3

  • Pregnancy
  • Breast feeding
  • Patient not available for follow up

Interventions

RADIATIONSBRT anticipated boost

24 Gy in 3 fractions to the tumour

Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT05673304

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