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Trial Title:
Preoperative Boost Associated With Neoadjuvant Chemotherapy in Luminal B Breast Cancer
NCT ID:
NCT05673304
Condition:
Breast Cancer
Radiotherapy
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Luminal B Breast Cancer
Neoadjuvant radiation therapy
Neoadjuvant chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT anticipated boost
Description:
24 Gy in 3 fractions to the tumour
Arm group label:
Interventional group
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.
Detailed description:
IBISCO TRIAL is a phase II trial aimed to demonstrate the improvement of pCR in Luminal B
breast cancer (BC) patients treated with stereotactic radiation therapy (SBRT) as an
anticipated boost associated with neoadjuvant chemotherapy (NAC).
The primary endpoint will be evaluated on surgical specimen using the residual cancer
burden (RCB) index.
Thirty patients with clinical stage T1-2 Luminal B BC, suitable for conservative surgery
and with a clinical indication for NAC, will be enrolled in two years. An observation
cohort will also be created with patients fulfilling inclusion criteria who refuse
enrollment in the interventional cohort and for patients where SBRT boost appears not
feasible after enrollment for technical issues.
As a secondary objective, histochemical and molecular analysis of the tumour and the
inflammatory microenvironment will be performed.
After the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine
therapy and whole breast irradiation) will be performed as for clinical practice
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Luminal B-like BC, cT1-2
- Indication for neoadjuvant chemotherapy
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Patient not available for follow up
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alice Zamagni, MD
Investigator:
Last name:
Alessio G Morganti, MD, PhD
Email:
Principal Investigator
Start date:
June 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency class:
Other
Source:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673304
