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Gene Expression Profiling to Help Define the Need for Neo-Adjuvant Chemotherapy in HR+, HER- Breast Cancer Patients

NCT05666258 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

GEP

GEP before surgery to determine need for neoadjuvant chemotherapy

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2024-11-14
Completion
2024-11-14

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05666258 on ClinicalTrials.gov