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

NCT ID: NCT00246090

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E7389

Intervention Type: DRUG

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

Interventions

E7389

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. 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.

4. 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.

5. Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy ≤ Grade 2 and alopecia.

6. Age >= 18 years.

7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

8. Life expectancy of ≥ 3 months.

9. Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.

10. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 10^9/L hemoglobin ≥ 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count ≥ 100 x 10^9/L.

11. Adequate liver function as evidenced by bilirubin ≤ 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 3 times the upper limits of normal (ULN) (in the case of liver metastases ≤ 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.

12. Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).

13. Willing and able to comply with the study protocol for the duration of the study.

14. Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Exclusion Criteria

1. 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.

2. 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).

3. Patients must not have pre-existing neuropathy > Grade 2.

4. Patients must not have participated in a prior E7389 clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Eisai Inc.

Principal Investigators

Dale Shuster, Ph.D.

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

Birmingham Hematology and Oncology

Birmingham, Alabama, United States

Birmingham Hematology and Oncology

Birmingham, Alabama, United States

Mercy Cancer Center

Hot Springs, Arkansas, United States

Arkansas Cancer Research Center

Little Rock, Arkansas, United States

Wilshire Oncology Medical Group, Inc.

La Verne, California, United States

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Center-Rose

Denver, Colorado, United States

Rocky Mountain Cancer Center

Littleton, Colorado, United States

Cancer Research Network

Plantation, Florida, United States

Hematology-Oncology Associates

Port Saint Lucie, Florida, United States

Dr. Elizabeth Tan-Chiu, PA

Tamarac, Florida, United States

Peachtree Hematology And Oncology Consultants

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Cancer Care and Hematology Specialist of Chicagoland

Niles, Illinois, United States

Central Indiana Cancer Center

Indianapolis, Indiana, United States

Monroe Medical Center

Munster, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Frederick Memorial Hospital, Regional Cancer Therapy Center

Frederick, Maryland, United States

Park Nicollet Institute

Minneapolis, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Montana Cancer Specialists

Missoula, Montana, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

New York Oncology Hematology, P.C

Albany, New York, United States

North Shore Hematology Oncology Associates

East Setakuet, New York, United States

Huntington Medical Group, PC

Huntington Station, New York, United States

Weill Cornell Breast Cancer Center

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Northwestern Carolina Oncology And Hematology, PA

Hudson, North Carolina, United States

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, United States

'Signal Point Hematology/Oncology, Inc.

Middletown, Ohio, United States

Medical University of Ohio

Toledo, Ohio, United States

Cancer Care Associates

Oklahoma City, Oklahoma, United States

Cancer Care Associates

Oklahoma City, Oklahoma, United States

Cancer Care Associates

Tulsa, Oklahoma, United States

Willamette Valley Cancer Center

Eugene, Oregon, United States

Northwest Cancer Specialist Rose Qtr

Portland, Oregon, United States

Kaiser Permanente, Central Interstate Clinic, Hematology Oncology

Portland, Oregon, United States

Northwest Cancer Specialist Hoyt

Portland, Oregon, United States

Charleston Hematology Oncology

Charleston, South Carolina, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Harrington Cancer Center

Amarillo, Texas, United States

Texas Oncology, P.A. Bedford

Bedford, Texas, United States

Center For Oncology Research and Treatment, PA

Dallas, Texas, United States

Texas Oncology PA

Dallas, Texas, United States

Sammons Cancer Center-Dallas

Dallas, Texas, United States

El Paso Cancer Treatment Center West

El Paso, Texas, United States

El Paso Cancer Treatment Center

El Paso, Texas, United States

Texas Oncology PA

Houston, Texas, United States

Baylor College of Medicine, Breast Cancer Clinic

Houston, Texas, United States

North Texas Regional Cancer Center

Plano, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Valley Oncology PA

Weslaco, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Fairfax Northern VA Hematology Oncology PC

Fairfax, Virginia, United States

Oncology and Hematology Associates

Salem, Virginia, United States

Cancer Care Northwest

Spokane, Washington, United States

Northwest Cancer Specialist

Vancouver, Washington, United States

Yakima Valley Memorial Hospital

Yakima, Washington, United States

Hamilton Health Sciences Juravinski Cancer Centre

Hamilton, Ontario, Canada

NW Ontario Regional Cancer Centre

Thunder Bay, Ontario, Canada

Toronto East General Hospital

Toronto, Ontario, Canada

Centre Hospitaliere Universitaire de Montreal

Montreal, Quebec, Canada

McGill University, Dept. of Oncology, Clinical Research Program

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 24682463 (View on PubMed)

Other Identifiers

2005-003656-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7389-G000-211

Identifier Type: -

Identifier Source: org_study_id