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)

ClinicalTrials.gov ID: NCT02753595

Public ClinicalTrials.gov record NCT02753595. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 12, 2026, 2:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-label, Multicenter, Phase 1b/2 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the metastatic setting. For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC previously treated with up to 2 lines of systemic anticancer therapy in the metastatic setting.

Study identification

NCT ID: NCT02753595
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Eisai Inc.; Industry
Enrollment: 25 participants

Conditions and interventions

Conditions

Metastatic Breast Cancer

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 12, 2016
Primary completion: Aug 15, 2019
Completion: Aug 15, 2019
Last update posted: Jul 12, 2020

2016 – 2019

United States locations

U.S. sites: 7
U.S. states: 6
U.S. cities: 7

Facility	City	State	ZIP	Site status
Not listed	Whittier	California	90602	—
Not listed	Atlanta	Georgia	30318	—
Not listed	Newnan	Georgia	30265	—
Not listed	Anderson	Indiana	46011	—
Not listed	Bethesda	Maryland	20817	—
Not listed	Stony Brook	New York	11794	—
Not listed	Kennewick	Washington	99336	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02753595, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 12, 2020 · Synced Sep 12, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02753595 live on ClinicalTrials.gov.

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