Table 2.
Clinical trials of therapeutic agents targeting breast cancer stem-like cells.
| NCT Number | Clinical Trial | Drug Name | BCSCs Biomarker Evaluated | Sample Size | Status |
|---|---|---|---|---|---|
| NCT01190345 | Anticancer Stem Cell Activity of Preoperative Bevacizumab and Chemotherapy in Breast Cancer (AVASTEM) | Bevacizumab is mAb anti-VEGF | In tissue samples, ALDH1 activity was measured | 75 patients with BC | Phase II, completed |
|
NCT01424865 |
Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial | Trastuzumab is an mAb anti-HER2 | In tissue samples, ALDH1 activity was measured | 1874 samples from patients with breast cancer | Unknown |
| NCT01973309 | A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer | Vantictumab is a mAb binds to frizzled receptors and inhibits canonical WNT signaling | not specified | 37 patients with locally recurrent or metastatic BC | Phase Ib, completed |
| NCT02254005 | Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer | Bivatuzumab is an mAb anti-CD44v6 | not specified | 24 patients with CD44v6-positive metastatic BC | Phase I, completed |
| NCT02915445 | EpCAM CAR-T for Treatment of Nasopharyngeal Carcinoma and Breast Cancer | EpCAM CAR-T are T cells with the chimeric antigen receptor (CAR-T) that recognize EpCAM | Persistence of EpCAM-positive circulating tumor cells | 30 patients with nasopharyngeal carcinoma or BC | Phase I, unknown |
|
NCT02776917 |
Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer | Cirmtuzumab is a monoclonal antibody that binds to receptor-tyrosine-kinase like orphan receptor 1 (ROR1) | ALDH1 and CD133 expression were evaluated in primary tumor samples before and after treatment | 22 patients with metastatic, or locally advanced, unresectable BC | Phase I, active |
| NCT00645333 | Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer | MK-0752 is a Gamma-secretase inhibitors | In tumor biopsies, the markers CD44, CD24, and ALDH1 were evaluated | 30 patients with advanced BC | Phase I/II, completed |
| NCT01149356 | RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer | RO4929097 is a gamma-secretase inhibitors. Exemestane is an aromatase inhibitor |
not specified | 15 patients with estrogen receptor-positive metastatic BC | Phase I, completed |
| NCT01876251 | A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cance | PF-03084014 is a selective gamma-secretase inhibitor | not specified | 30 advanced BC | Phase I, completed |
| NCT02299635 | A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations | PF-03084014 is a selective gamma-secretase inhibitor | Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway | 19 advanced triple receptor-negative BC | Phase II, completed |
| NCT01351103 | A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands | LGK974 is an inhibitor of Wnt signaling and PDR001 (anti-PD-1) | not specified | 185 patients with solid malignancies (TNBC) | Phase I, Recruiting |
| NCT01861054 | Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer | Reparixin is inhibitor of the CXCR1 receptor | In tissue samples, the activity of ALDH1 and markers such as CD44, CD24, Snail, Twist, and Notch were measured | 20 patients with early BC | Phase II, completed |
| NCT02370238 | A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer (FRIDA) | Reparixin is inhibitor of the CXCR1 receptor |
In Metastatic tissue samples, the expression CD24, CD44, and ALDH1 was evaluated | 194 patients with metastatic TNBC | Phase II, completed |
| NCT01118975 | Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers | Vorinostat is a histone deacetylase inhibitor. Lapatinib is a dual EGFR and HER2 inhibitor |
Biomarkers of EMT and BCSCs | 12 patients HER2-positive metastatic BC | Phase II, completed |
| NCT01868503 | Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer | Lapatinib Ditosylate and Radiation Therapy | BCSC ratio and gene expression | Seven advanced or recurrent in BC | Phase II, completed |
| NCT00524303 | Lapatinib +/− Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy | Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel | not specified | 100 patients with invasive BC overexpressing HER2 | Phase II, completed |
| NCT02876302 | Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple-Negative Inflammatory Breast Cancer | Ruxolitinib blocks the IL6/JAK/Stat pathway | Distribution of the CD44+/CD24− stem cell population and the inhibition of JAK and pStat3 expression | 23 | Phase II, Active |
| NCT00949013 | S9313B Study of Tumor Tissue Samples from Women With Early-Stage Breast Cancer Enrolled on Clinical Trial SWOG-9313 | Doxorubicin and cyclophosphamide |
In tissue samples, ALDH1 was measured | 1600 patients early-stage BC | Completed |
mAb: monoclonal antibody; BC: breast cancer; BCSC: breast cancer stem cell; EMT: epithelial–mesenchymal transition; ALDH: aldehyde dehydrogenase; CXCR: CXC chemokine receptor; HER2: human epidermal growth factor receptor 2; VEGF: vascular endothelial growth factor receptor; EGFR: human epidermal growth factor receptor.