Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

Eisai Inc.52 enrolled

Overview

This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Eribulin MesylateDRUG

Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion criteria: * Age 18 years or older * Histologically or cytologically proven adenocarcinoma of the breast * Subjects who have locally recurrent or metastatic disease with at least one measurable lesion * HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2 * At least 12 months since prior neoadjuvant or adjuvant chemotherapy * At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions * Adequate renal function * Adequate bone marrow function * Adequate liver function * Adequate cardiac function Key Exclusion criteria: * Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer. * Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer * Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin * Inflammatory breast cancer * Prior history of hypertensive crisis or hypertensive encephalopathy * Clinically significant cardiovascular impairment * Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis. * Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) * Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen * History of bleeding diasthesis * Currently pregnant or breast-feeding. * Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment

Locations (26)

Outcomes

Primary Outcomes

Objective Response Rate

The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.

Time frame: Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR

Secondary Outcomes

Time to First Response

Time to first response was defined for participants whose best overall response was a CR or PR.

Time frame: From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months

Duration of Response (DOR)

Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.

Time frame: Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months

Progression-Free Survival (PFS)

Data from ClinicalTrials.gov

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