A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine

NCT00246090 | Completed Phase 2 Results

• 2 other identifiers: E7389-G000-2112005-003656-35
• Study Type: interventional
• Target: 298
• Locations: 2 countries
• Sites: 65

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

  Every two cycles

Secondary Outcomes (1)

• Duration of Response

  From first documented complete or partial response until disease progression or death

Study Arms (1)

1

EXPERIMENTAL

Drug: E7389

Interventions

E7389 DRUG

E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
• Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.
• Prior therapy must be documented by the following criteria prior to entry onto study:
• Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.
• One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.
• Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.
• Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.
• Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.
• Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.
• Progression on or within six months of the last regimen for advanced disease, documented by the following:
• The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.
• Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.
• Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.
• Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter \[LD\] by spiral computer tomography \[CT\] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.
• Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy ≤ Grade 2 and alopecia.

You may not qualify if:

• Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.
• Patients must not have received radiation therapy encompassing \> 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).
• Patients must not have pre-existing neuropathy \> Grade 2.
• Patients must not have participated in a prior E7389 clinical trial.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Limited: collaborator

Study Sites (65)

Birmingham Hematology and Oncology

Birmingham, Alabama, 35205, United States

Location

Birmingham Hematology and Oncology

Birmingham, Alabama, 35213, United States

Location

Mercy Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Arkansas Cancer Research Center

Little Rock, Arkansas, 72205, United States

Location

Wilshire Oncology Medical Group, Inc.

La Verne, California, 91750, United States

Location

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Center-Rose

Denver, Colorado, 80220, United States

Location

Rocky Mountain Cancer Center

Littleton, Colorado, 80210, United States

Location

Cancer Research Network

Plantation, Florida, 33324, United States

Location

Hematology-Oncology Associates

Port Saint Lucie, Florida, 34952, United States

Location

Dr. Elizabeth Tan-Chiu, PA

Tamarac, Florida, 33321, United States

Location

Peachtree Hematology And Oncology Consultants

Atlanta, Georgia, 30309, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Cancer Care and Hematology Specialist of Chicagoland

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Center

Indianapolis, Indiana, 46227, United States

Location

Monroe Medical Center

Munster, Indiana, 46321, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Frederick Memorial Hospital, Regional Cancer Therapy Center

Frederick, Maryland, 21701, United States

Location

Park Nicollet Institute

Minneapolis, Minnesota, 55416, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

New York Oncology Hematology, P.C

Albany, New York, 12208, United States

Location

North Shore Hematology Oncology Associates

East Setakuet, New York, 11733, United States

Location

Huntington Medical Group, PC

Huntington Station, New York, 11746, United States

Location

Weill Cornell Breast Cancer Center

New York, New York, 10021, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Northwestern Carolina Oncology And Hematology, PA

Hudson, North Carolina, 28602, United States

Location

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, 27511, United States

Location

'Signal Point Hematology/Oncology, Inc.

Middletown, Ohio, 45042, United States

Location

Medical University of Ohio

Toledo, Ohio, 43614, United States

Location

Cancer Care Associates

Oklahoma City, Oklahoma, 73112, United States

Location

Cancer Care Associates

Oklahoma City, Oklahoma, 73120, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 74136, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Northwest Cancer Specialist Rose Qtr

Portland, Oregon, 97225, United States

Location

Kaiser Permanente, Central Interstate Clinic, Hematology Oncology

Portland, Oregon, 97227, United States

Location

Northwest Cancer Specialist Hoyt

Portland, Oregon, 97227, United States

Location

Charleston Hematology Oncology

Charleston, South Carolina, 29403, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Texas Oncology, P.A. Bedford

Bedford, Texas, 76022, United States

Location

Center For Oncology Research and Treatment, PA

Dallas, Texas, 75230, United States

Location

Texas Oncology PA

Dallas, Texas, 75231, United States

Location

Sammons Cancer Center-Dallas

Dallas, Texas, 75246, United States

Location

El Paso Cancer Treatment Center West

El Paso, Texas, 79902, United States

Location

El Paso Cancer Treatment Center

El Paso, Texas, 79915, United States

Location

Texas Oncology PA

Houston, Texas, 77024, United States

Location

Baylor College of Medicine, Breast Cancer Clinic

Houston, Texas, 77030, United States

Location

North Texas Regional Cancer Center

Plano, Texas, 75075, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Valley Oncology PA

Weslaco, Texas, 78596, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

Fairfax Northern VA Hematology Oncology PC

Fairfax, Virginia, 22031, United States

Location

Oncology and Hematology Associates

Salem, Virginia, 24153, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

Northwest Cancer Specialist

Vancouver, Washington, 98684, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Hamilton Health Sciences Juravinski Cancer Centre

Hamilton, Ontario, L8VSC2, Canada

Location

NW Ontario Regional Cancer Centre

Thunder Bay, Ontario, P7B6V4, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C3E7, Canada

Location

Centre Hospitaliere Universitaire de Montreal

Montreal, Quebec, H2L4MI, Canada

Location

McGill University, Dept. of Oncology, Clinical Research Program

Montreal, Quebec, H2W1S6, Canada

Location

Related Publications (1)

• Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

  PMID: 24682463 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Dale Shuster, Ph.D.

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 14, 2014
• Results First Posted: May 15, 2012

Record last verified: 2012-04

Locations

CA (5); US (60)