Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 13, 2016

Primary Completion Date

August 16, 2019

Study Completion Date

August 16, 2019

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Eribulin mesylate

Eribulin mesylate will be administered at 1.4 mg/m\^2 or 1.1 mg/m\^2 as intravenous (IV) infusion on Day 1 and 8 of 21-day cycle

DRUG

Eribulin mesylate

Eribulin mesylate will be administered at 1.4 mg/m\^2 or 1.1 mg/m\^2, depending on RP2D, as IV infusion on Day 1 and 8 of each 21-day cycle

DRUG

Eribulin mesylate

Eribulin mesylate will be administered at 1.4 mg/m\^2 as IV infusion on Day 1 and 8 of 21-day cycle

OTHER

Biologic: PEGylated recombinant human hyaluronidase (PEGPH20)

PEGPH20 will be administered at 3.0 mcg/kg or 1.6 mcg/kg as IV infusion on Day -1 and 7 of 21-day cycle

OTHER

Biologic: PEGylated recombinant human hyaluronidase

PEGPH20 will be administered at 3.0 mcg/kg or 1.6 mcg/kg, depending on RP2D, as IV infusion on Day -1 and 7 of each 21-day cycle

Trial Locations (7)

11794

Stony Brook

20817

Bethesda

30265

Newnan

30318

Atlanta

46011

Anderson

90602

Whittier

99336

Kennewick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Halozyme Therapeutics

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT02753595 - Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC) | Biotech Hunter | Biotech Hunter