NCT05871788Not yet recruiting
Biomarkers in Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 23 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1600 (estimated)
- First submitted
- 13 May 2023
- Start date
- Jun 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Tunisian Association for Immuno-oncology Research
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05871788
What you commit to
- Study type: Observational
- Planned participants: 1600
- From Jun 2023 to the primary completion date, Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Non-epithelial breast cancer
Other
- Non-biopsiable metastases
- Foreign patients
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.