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

NCT ID: NCT05666258

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2024-11-14

Brief 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

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

GEP

GEP before surgery to determine need for neoadjuvant chemotherapy

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Mammaprint

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ine Luyten, MD

Role: CONTACT

borstkliniek@uzbrussel.be

02 477 6015

Marian Vanhoeij

Role: CONTACT

borstkliniek@uzbrussel.be

02 477 6015

Facility Contacts

Ine Luyten, MD

Role: primary

borstkliniek@uzbrussel.be

02 477 6015

Other Identifiers

NACAGEP

Identifier Type: -

Identifier Source: org_study_id