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Table 1 The most recent clinical trials in TNBC patients in the search of therapeutic biomarkers for advanced disease

From: Long non-coding RNAs: implications in targeted diagnoses, prognosis, and improved therapeutic strategies in human non- and triple-negative breast cancer

Clinical trial Phase Study groups Indications Therapeutic target
NCT02623972 II Eribulin (Halaven®) by IV, for 4 cycles; followed by AC by IV, for 4 cycles Advanced TNBC Inhibitor of microtubule dynamics
NCT02120469 I Everolimus (Afinitor®) by OA daily; eribulin mesylate (Halaven®) by IV twice every month Metastatic TNBC mTOR inhibitor
NCT02672475 I Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off; Galunisertib (LY2157299), by OA, twice daily, 3 weeks on, 1 week off Metastatic TNBC Inhibitor of the TGF-β receptor I kinase
NCT02632071 I ACY-1215 (ricolinostat), by OA, daily for 3 weeks on, 1 week off; nab-paclitaxel (Abraxane®), by IV, weekly for 3 weeks on, 1 week off Advanced TNBC HDAC6 blocker
NCT02393794 I–II Romidepsin (Istodax®) by IV, twice every 3 weeks; cisplatin (Platinol®), by IV, every 3 weeks TNBC or BRCA1 or BRCA2 mutation-associated locally recurrent or metastatic BC HDAC inhibitor
NCT02425891 III Experimental group: MPDL3280a (atezolizumab), by IV; nab-paclitaxel (Abraxane®), by IV Control group: placebo; nab-paclitaxel (Abraxane®), by IV Locally advanced or metastatic TNBC Anti-PD-L1
NCT02366949 I Experimental group: BAY1217389, by OA, twice daily; paclitaxel (Taxol®) by IV, weekly Control group: paclitaxel (Taxol®) by IV, weekly Advanced TNBC MPS1
NCT02309177 I Group 1 nab-paclitaxel, by IV, weekly for 3 weeks every month; nivolumab (Opdivo®), by IV, every 2 weeks, starting at 3 months; group 2 nab-paclitaxel, by IV, once every 3 weeks 28/02/2017 nivolumab (Opdivo®), by IV, every 3 weeks, starting at 3 months HER2−, recurrent metastatic TNBC Anti-PD-1
NCT02595320 II Group 1: 1500 mg capacitabine (Xeloda®), by OA, twice daily, 1 week on, 1 week off; group 2: 1250 mg capacitabine (Xeloda®), by OA, twice daily, 2 weeks on, 1 week off Metastatic TNBC Alkylating agent; tumor-selective and tumor-activated cytotoxic agent
NCT02897375 I Group 1; palbociclib (Ibrance®), by OA, daily (3 weeks on, 1 week off); cisplatin (Platinol®), by IV, once, monthly; group 2: palbociclib (Ibrance®), by OA, daily (3 weeks on, 1 week off); carboplatin (Paraplatin®), by IV, once, monthly ER +, HER2− metastatic BC, advanced BC CDK inhibitor
NCT00978250 II FdCyd (5-fluoro-2′-deoxcytidine) and THU (tetrahydrouridine) by IV for 5 days per week for 2 weeks, followed by 2 weeks of no treatment Advanced BC FdCyd, a fluoropyrimidine nucleoside DNMT inhibitor, and THU,THU does not have any anticancer effects, but it can help keep the other drug
NCT02046421 I Mifepristone by OA on days 0, 1, 7, and 8; carboplatin (Paraplatin) and gemcitabine hydrochloride (Gemzar) by IV on days 1 and 8 Advanced BC GR antagonist
NCT02752685 II Pembrolizumab (Keytruda®), by IV, every 3 weeks; nab-paclitaxel (Taxotere®), by IV, weekly, 2 weeks on 1 week off HER2− metastatic BC Anti PD-1
NCT02915744 III Group 1: NKTR-102, by IV, once every 3 weeks, ongoing; group 2 treatment of physician’s choice (eribulin/Halaven®, ixabepilone/Ixempra®, vinorelbine/Navelbine®, gemcitabine/Gemzar®, paclitaxel/Taxol®, docetaxel/Taxotere® or nab-paclitaxel/Abraxane®), by IV Metastatic BC with brain metastases Topoisomerase I inhibitor
NCT02929576 III Group 1: Xtandi and Taxol, enzalutamide (Xtandi®), by OA, daily, ongoing, paclitaxel (Taxol®), by IV, weekly for 16 weeks; group 2: placebo and Taxol, placebo, by OA, daily, ongoing, paclitaxel (Taxol®), by IV, weekly for 16 weeks; group 3: Xtandi followed by Taxol, enzalutamide (Xtandi), by OA, daily, ongoing, followed by paclitaxel (Taxol®), by IV, weekly for 16 weeks Advanced TNBC Synthetic non-steroidal antiandrogen
NCT02163694 III Group 1: experimental: veliparib by OA, on days 2 through 5, carboplatin (Paraplatin®) and paclitaxel (Taxol®) by IV, once every 3 weeks; group 2: control: placebo by OA on days 2 through 5, carboplatin and paclitaxel by IV, once every 3 weeks Advanced HER2− BCr with BRCA1 or BRCA2 mutation PARP inhibitor
NCT02187991 II Group 1: paclitaxel (Taxol®), by IV, 3 times a month, ongoing; Group 2: paclitaxel (Taxol®), by IV, 3 times a month, ongoing, alisertib, by OA, 3 times a week, ongoing ER+/HER2− or advanced TNBC Aurora A kinase inhibitor
NCT01990352 II Doxil® (pegylated liposomal doxorubicin hydrochloride), by IV, every 3 weeks Metastatic TNBC Liposoma
NCT01999738 I EC1456 by injection, twice a week on weeks 1 and 2 of every month Metastatic TNBC Injectable targeted SMDC consisting of folate (vitamin B9; a folate receptors agonist) covalently linked to the potent mitotic poison and cytotoxic agent, tubulysin B hydrazide (Tub-B-H, a tubulin polymerization inhibitor)
NCT02950064 I BTP-114, by IV, once every 3 weeks, ongoing Advanced TNBC with a BRCA 1/2 mutation Albumin-binding cisplatin prodrug
NCT01802970 I Anakinra (Kineret®) alone, by OA, for 2 weeks followed by: anakinra (Kineret®), by OA, nab-paclitaxel (Abraxane®) by IV weekly, for a maximum of 6 months Advanced BC IL-1 receptor antagonist, an anti-inflammatory
NCT02000882 II BKM120 by OA daily; capecitabine by OA twice a day, for 2 weeks on, 1 week off, ongoing TNBC with brain metastases PI3K inhibitor
NCT02379247 I–II BYL719, by OA, daily; nab-paclitaxel (Abraxane®) by IV, weekly for 3 out of every 4 weeks Advanced HER2-negative BC PI3K inhibitor
NCT02624700 II Pemetrexed, by IV, every 2 weeks; sorafenib, by OA, twice daily for 5 days Recurrent or metastatic TNBC Small inhibitor of several tyrosine protein kinases, such as VEGFR, PDGFR, and Raf family kinases (more avidly C-Raf than B-Raf)
NCT02978716 II Group 1: chemotherapy only, gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, on days 1 and 8, ongoing; group 2: trilaciclib and chemotherapy, trilaciclib (G1T28), by IV, on days 1 and 8, ongoing, gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, on days 1 and 8, ongoing; group 3: trilaciclib and chemotherapy, trilaciclib (G1T28), by IV, on days 1, 2, 8, 9, ongoing, gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, on days 2 and 9, ongoing Recurrent or metastatic TNBC CDK4/6 inhibitor
NCT02753595 I–I Eribulin mesylate (Halaven®), by IV, weekly (2 weeks on, 1 week off); PEGPH20, by IV, weekly (2 weeks on 1 week off) HER2− metastatic BC Pegylated recombinant human PH20 degrades hyaluronic acid (HA) coating tumor cells
NCT02762981 I–II CORT125134, by OA, daily, ongoing; nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on 1 week off), ongoing Advanced BC GR antagonist
  1. Intravenous IV, oral administration OA, AC Adriamycin® and Cytoxan®, mTOR mammalian target of rapamycin, HDAC6 histone deacetylase 6, BRCA1/2 breast cancer 1/2, PD-L1 programmed cell death ligand-1, MPS1 serine/threonine kinase monopolar spindle 1, HER2 human epidermal growth factor receptor 2, PD-1 programmed cell death receptor, ES+ estrogen receptor positive, CDK cyclin-dependent kinase, FdCyd 5-fluoro-2′-deoxcytidine, THU tetrahydrouridine, DNMT DNA methyltransferase, GR glucocorticoid receptor, PARP poly (ADP-ribose) polymerase, SMDC small molecule drug conjugate, IL1 Interleukin-1, PI3K phosphatidylinositol 3-kinase, VEGF vascular endothelial growth factor, PDGF-R platelet-derived growth factor receptors