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

NCT05666258 | Unknown

• 1 other identifier: NACAGEP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Neoadjuvant chemotherapy; GEP

Outcome Measures

Primary Outcomes (1)

• De-escalation of breast cancer surgery

  Number of patients who receive NAC after a high-risk GEP that will undergo TAD instead of ALND and/or undergo BCS instead of mastectomy

  8 months after inclusion

Interventions

GEP DIAGNOSTIC_TEST

GEP before surgery to determine need for neoadjuvant chemotherapy

Also known as: Mammaprint

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Breast Clinic

You may qualify if:

• Tumour characteristics: HR+, HER-
• Histopathological tumour characteristics: cT1-3, cN1, cM0, all histological types included
• Age: 18-85 years

You may not qualify if:

• Tumour characteristics: cT4, cN2-3, cM1
• Age: \<18 or \>85 years old
• Received chemotherapy in the last 5 years
• Pregnancy

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsy

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ine Luyten, MD

CONTACT

02 477 6015; borstkliniek@uzbrussel.be

Marian Vanhoeij

CONTACT

02 477 6015; borstkliniek@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: November 14, 2022
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

BE (1)