Biomarkers in Patients With Metastatic Breast Cancer

Trial Title: Biomarkers in Patients With Metastatic Breast Cancer

NCT ID: NCT05871788

Condition: Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia

Study type: Observational [Patient Registry]

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: identify biomarkers
Description: Identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma

Summary: In order to allow Tunisian patients with breast cancer to access immunotherapies, and innovative treatments to extend life expectancy of patients with breast cancer with a poor prognosis, it is important to study the epidemiological profile of Tunisian cancers breast, in terms of PD-L1 expression, tumor mutational burden (TMB), microsatellite instability status (MSI) and rate of TILs, in metastatic and locally advanced cases, in Tunis, over a one-year follow-up period. It is also important to study other inflammatory and tumor biomarkers which would have a prognostic or even therapeutic value: - serum dosage of LDH (lactate dehydrogenase) - IL-6 (interleukin 6) - CRP (C-reactive protein) - absolute count of lymphocytes (CLA) and eosinophils - quantification of circulating tumor DNA before treatment and under treatment. The primary objective id to identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma before and during the systemic treatment.

Detailed description: Procedure: 1. Verification of the inclusion / non-inclusion criteria 2. Signing the consent form 3. Surgical, Medical and family history, ongoing treatments 4. Clinical Examination1 5. Radiological examinations 2 6. TNM Classification (Appendix 3) 7. Standard biochemical assessment 3 8. Inflammatory assessment (CRP, LDH, IL6) 9. Hematological assessment (NFS, platelets) 10. Tumor markers (ACE, CA15-3) 11. Histological and molecular examination 4: - Expression PD-L1 by IHC (Immuno-Histochemistry) - TILs by IHC - - MSI status: MMR * proteins (Mismatch Repair Protein) (Appendix 4) by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1% - Score HRD : by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1>1% - TMB mutational burden by next generation sequencing "Next Generation Sequencing" (NGS) via TruSight™ Oncology 500 Kit (Illumina) if PD-L1>1% - tDNA by digital PCR 12. Radiological evaluation5 13. Indication of surgery? (if yes type of surgery to be specified) 14. Evaluation of adverse events / effects: Tolerance of the previous treatment 15. Completion the source documents and the eCRF Clinical Exam1: - General State according to the WHO classification or according to the Karnowsky Index - Breast examination: inspection (symmetry, appearance of the skin), palpation (size of the tumor, presence of mammary discharge). - Examination of the axillary and supraclavicular lymph node areas - Abdominal examination - Pulmonary auscultation - Skeleton examination Radiological examination2: - Mammography and echo-mammary - Thoraco-abdomino-pelvic CT scan - Bone scintigraphy - Cardiac ultrasound Standard biochemical balance3: Blood group, creatininemia, blood ionogram, calcemia, glycemia, bilirubin, transaminases, gamma-GT, alkaline phosphatases, total cholesterol, triglycerides, uric acid, albuminemia. Histological examination4: - Biopsy with part number assigned by the laboratory, name of the laboratory - Histological type - Grade of Scarff-Bloom and Richardson (SBR) - Estrogen receptors, progesterone receptors - Her2Neu - Ki67 - PD-L1 - TILs - MMR Molecular Examination4: - MSI status by pentaplex PCR and capillary electrophoresis by NGS platform via the TruSight™ kit Oncology 500 (Illumina) - HRD Score by NGS platform via the TruSight™ kit Oncology 500 (Illumina) - Mutational burden TMB by NGS platform via the TruSight™ kit Oncology 500 (Illumina) - Circulating tumor DNA by digital PCR Radiological assessment5: - If the stage is locally advanced (appendix 3): Breast ultrasound +/- Mammography +/- Breast MRI - If metastatic stage: Thoraco-abdomino-pelvic CT scan 12 | 27 Visit details • Initial visit D0 (V1) - Signature of informed consent form - Verification of inclusion / non-inclusion criteria - Medical, surgical and family history - Current treatments - Clinical examination1 - Radiological examinations2 - TNM classification - Standard biochemical assessment3 - Inflammatory assessment (CRP, LDH, IL6) - Hematological assessment (NFS, platelets) - Tumor markers (ACE, CA15-3) - Histological examination with immunohistochemistry and molecular4: - Biopsy with part number assigned by the lab, name of the lab - Histological type - SBR grade - Estrogen receptors, progesterone receptors - Her2Neu - Ki67 - PD-L1 - TILs - MMR - MSI - HRD - TMB mutational charge - ctDNA o Completion of source documents and eCRF - Visit after 3 chemotherapy treatment cycles (V2) - Current treatments - Clinical examination1 - Hematological assessment (NFS, platelets) - Tumor markers (ACE, CA15-3) - Radiological assessment5 - Evaluation of adverse events / effects: Tolerance of the previous treatment - Completion of source documents and eCRF - Assessment visit (V3) o Current treatments o Clinical examination1 - TNM classification - Inflammatory assessment (CRP, LDH, IL6) - Hematological assessment (NFS, platelets) - Tumor markers (ACE, CA15-3) - Histological examination with immunohistochemistry and molecular4: - Biopsy with part number assigned by the lab, name of the lab - Histological type - SBR grade 13 | 27 - Estrogen receptors, progesterone receptors - Her2Neu - Ki67 - PD-L1 - TILs - ctDNA o Radiological assessment5 o Assessment of adverse events / effects o Fill in the source files and the eCRF - Follow-up visit at 3 months (V4) o Current treatments o Clinical examination1 o Tumor markers (ACE, CA15-3) o Radiological examinations2 o Evaluation of adverse events / effects - Completion of source documents and eCRF - Follow-up visit at 6 months (V5) o Current treatments o Clinical examination1 o Tumor markers (ACE, CA15-3) - Radiological examinations2 - Evaluation of adverse events / effects - Completion of source documents and eCRF

Criteria for eligibility:

Study pop:
Patients with metastatic or locally advanced breast cancer in Tunis, Tunisia.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - Age ≥ 18 years old. - Signed informed consent - Histological evidence of breast carcinoma. - Locally advanced (stage III inoperable) or metastatic (stage IV) carcinoma, the metastases of which have been diagnosed straight away or after adjuvant or neoadjuvant treatment. - No treatment for metastatic disease. - Metastatic disease: histological evidence of metastasis - Patients who will receive systemic treatment (chemotherapy, targeted therapy, hormone therapy) - Life expectancy greater than 3 months Exclusion Criteria: - Non-epithelial breast cancer - Non-biopsiable metastases - Patients who have received before systemic treatment for metastatic disease (chemotherapy, targeted therapy, hormone therapy) - Patients with a contraindication to chemotherapy, and / or hormone therapy, and / or targeted therapy. - Foreign patients

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 2023

Completion date: December 2027

Lead sponsor:
Agency: Tunisian Association for Immuno-oncology Research
Agency class: Other

Source: Tunisian Association for Immuno-oncology Research

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05871788