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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Recruiting

CT.gov ID

NCT05666258

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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 we were able to identify patients requiring chemotherapy prior to surgery, we could treat them with Neo-Adjuvant Chemotherapy (NAC) instead. By using MammaPrint® GEP, we 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Diagnostic Test: GEP

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Nov 14, 2024

Anticipated Study Completion Date :

Nov 14, 2024

Outcome Measures

Primary Outcome Measures

De-escalation of breast cancer surgery [8 months after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Jette	Brussel	Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT05666258

Other Study ID Numbers:

NACAGEP

First Posted:

Dec 27, 2022

Last Update Posted:

Dec 27, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitair Ziekenhuis Brussel

Neoadjuvant chemotherapy

GEP

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Dec 27, 2022