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Trial Title:
Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR+, HER- Breast Cancer Patients
NCT ID:
NCT05666258
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Neoadjuvant chemotherapy
GEP
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
GEP
Description:
GEP before surgery to determine need for neoadjuvant chemotherapy
Other name:
Mammaprint
Summary:
The goal of the experiment is surgical de-escalation. Patients with newly diagnosed
cT1-3, cN1, cM0 and HR+, HER2- breast cancer and low clinical risk usually first receive
breast cancer surgery, after which chemotherapy can be added based on the final
anatomopathological results or additional Gene Expression Profiling (GEP) testing.
Chemotherapy helps reduce the cancer recurrence or metastasis risk. Adjuvant chemotherapy
(AC) can be given for large tumours, aggressive tumours with high grade tumour cells, or
if axillary lymph node invasion is discovered during surgery. If the investigators were
able to identify patients requiring chemotherapy prior to surgery, they could treat them
with Neo-Adjuvant Chemotherapy (NAC) instead. By using MammaPrint® GEP, the investigators
would be able to stratify patients into either a low- or high-risk category. Since the
high-risk group is known to benefit from chemotherapy to improve overall survival, they
would be treated with NAC, which could also potentially lead to surgical de-escalation.
Breast conserving procedures, such as a lumpectomy instead of a mastectomy, could allow
more aesthetically pleasing results and increase patient quality of life. Using NAC for
patients with axillary lymph node invasion could lead to nodal complete pathological
response (cN1 -> ypN0), allowing patients that are willing to enter the TADANAC trial a
lymph node sparing procedure instead of a full axillary lymph node dissection.
Criteria for eligibility:
Study pop:
Patients of the Breast Clinic
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Tumour characteristics: HR+, HER-
- Histopathological tumour characteristics: cT1-3, cN1, cM0, all histological types
included
- Age: 18-85 years
Exclusion Criteria:
- Tumour characteristics: cT4, cN2-3, cM1
- Age: <18 or >85 years old
- Received chemotherapy in the last 5 years
- Pregnancy
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitair Ziekenhuis Brussel
Address:
City:
Jette
Zip:
1090
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ine Luyten, MD
Phone:
02 477 6015
Email:
borstkliniek@uzbrussel.be
Start date:
November 14, 2022
Completion date:
November 14, 2024
Lead sponsor:
Agency:
Universitair Ziekenhuis Brussel
Agency class:
Other
Source:
Universitair Ziekenhuis Brussel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05666258
