Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR)

Outcome Description:

Defined as the proportion of subjects who have a best overall response of confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as determined by the investigator.

Outcome Time Frame:

30 months

Safety Issue:

No

Principal Investigator

Jessica Rege, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7389-A001-208

NCT ID:

NCT01269346

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Locally recurrent or metastatic HER2Positive breast cancer
  • Breast Neoplasms

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Ocala Oncology CenterOcala, Florida  34474
University of ColoradoDenver, Colorado  80217
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
Florida Oncology AssociatesOrange Park, Florida  32073
Medical Oncology Associates of Wyoming Valley, P.C.Kingston, Pennsylvania  18704-5527
Peninsula Cancer InstituteNewport News, Virginia  23601
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Montgomery Cancer CenterMt. Sterling, Kentucky  40353
C. Michael Jones, MDGermantown, Tennessee  38138
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Florida Cancer CareDavie, Florida  33328
Texas Oncology - Memorial CityHouston, Texas  77024
Texas Oncology - Sugar LandSugar Land, Texas  77479
Texas Oncology - El Paso Cancer Treatment Center GrandviewEl Paso, Texas  79915
Texas Oncology - Medical City DallasDallas, Texas  
Peachtree Hematology Oncology Associates, PCAtlanta, Georgia  30309
Weill Cornell Breast ClinicNew York, New York  10065
Raleigh Hematology AssociatesRaleigh, North Carolina  27607
Cancer Care of the CascadesBend, Oregon  97701
Charleston Hematology / OncologyCharleston, South Carolina  29403
Texas Oncology - Beaumont Marnie McFaddin Ward Cancer CenterBeaumont, Texas  77702-1449
Texas Oncology - McAllen South Second StreetMcAllen, Texas  78503
Texas Oncology - ShermanSherman, Texas  75090-0504