Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: December 31, 2010
Last updated: November 11, 2013
Last verified: November 2013
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.
Drug: Eribulin Mesylate
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2, Multicenter, Single-Arm Study of Eribulin Mesylate With Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Experimental: Experimental 1
Drug: Eribulin Mesylate
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2 mitoxantrone, > 90 mg/m2 idarubicin, or > 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 </= 2 before enrollment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269346
||Jessica Rege, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 31, 2010
||November 11, 2013
||United States: Food and Drug Administration
Keywords provided by Eisai Inc.:
Locally recurrent or metastatic HER2Positive breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 23, 2014
Neoplasms by Site