Breast Carcinoma Clinical Trial
Official title:
Circulating microRNA 21 Expression Level Before and After Neoadjuvant Systemic Therapy in Breast Carcinoma
MicroRNAs (miRNAs) are involved in the development and progression of malignant tumors. In breast cancer, differential miRNA expression has been demonstrated across breast cancer subtypes, with both tumor-promoting and tumor suppressive functions for individual miRNAs. Novel predictive biomarkers that can be assessed in the liquid specimen before systemic treatment could help to individualize treatment decisions in breast cancer and to potentially avoid ineffective systemic treatment. In our study we detect level of circulating miRNA 21 in breast cancer patient before and after neoadjuvant treatment , whether there will be change or not, and if related to complete pathological response.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | January 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >/= 18 years old. - Breast cancer diagnosis histologically proven and pathology report from breast and ipsilateral axillary nodes. - Pathology: invasive carcinoma. - Staging: tumor size >2cm (>/=T2), node positive (N >/= 1), i.e. >/= T2N1; from stage IIB to stage IIIC, according to AJCC breast Cancer staging 8th edition. (Giuliano, Edge and Hortobagyi, 2018) - All subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative. - Neoadjuvant systemic treatment composed of anthracyclines-based chemotherapy and taxanes, trastuzumab for HER2 positive patients Exclusion Criteria: - Metastatic breast cancer - inflammatory breast cancer, - male breast cancer, - bilateral breast cancer, or concurrent malignancy - Previous malignancy. - Presence of any contraindication to neoadjuvant treatment |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Describe miRNA 21 expression level before and after neoadjuvant systemic therapy in breast cancer patient. | miRNA 21 expression level before and after neoadjuvant systemic therapy | 1 year | |
Secondary | Measure relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response. | Relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response | 1 year | |
Secondary | Measure relation between the miRNA 21 expression and the clinicopathological parameters of Breast Cancer patients. | Relation between the miRNA 21 expression and the clinicopathological parameters | 1 year |
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