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

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