Study to Evaluate the Efficacy, Safety, and Tolerability of E7070 in Metastatic Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080197
Recruitment Status : Completed
First Posted : March 25, 2004
Last Update Posted : October 11, 2006
Information provided by:
Eisai Inc.

Brief Summary:
The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Metastases Drug: E7070 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Study Start Date : February 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Objective Response Rate

Secondary Outcome Measures :
  1. Duration of Response
  2. Time-to-Progression
  3. Overall Survival
  4. Safety
  5. Tolerability
  6. Quality of Life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be female,
  • Patients must have histologically or cytologically confirmed metastatic breast cancer,
  • Patients must either have tumors that are resistant/refractory to chemotherapy with an anthracycline, a taxane, capecitabine, and appropriate Herceptin therapy, or tumors that cannot be treated with these agents due to patient’s treatment toxicity; therefore, patients must have received 2 prior chemotherapies but no more than 3 prior chemotherapies in the metastatic setting,
  • Patients must have at least one uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated,
  • Patients must be aged >= 18 years,
  • Patients must have a Karnofsky Performance Status of >= 70%,
  • Patients must have a life expectancy of >= 3 months,
  • Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL, or if > 1.5 but <= 1.8 mg/dL, then a creatinine clearance of >= 45 mL/min,
  • Patients must have adequate bone marrow function as evidenced by absolute neutrophil count of >= 1.5 x 109/L, hemoglobin >= 9.0 g/dL, and platelet count >= 100 x 109/L,
  • Patients must have adequate liver function as evidenced by bilirubin of <= 1.5 times the upper limits of normal (ULN); alkaline phosphatase <= 3 times ULN and alanine transaminase (ALT) and aspartate transaminase (AST) <= 3 times ULN, unless related to liver metastasis, in which case <= 5 x ULN,
  • Patients must have serum electrolytes including calcium (corrected for albumin), magnesium, and potassium (corrected) within normal limits,
  • Patients must be willing and able to complete the FACT-B questionnaire,
  • Patients must be willing and able to comply with the study protocol for the duration of the study, and
  • Patients must give 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:

  • Patients must not have metastatic disease that can be completely surgically resected,
  • Patients who received adjuvant taxane must not have experienced disease progression within 12 months of beginning that therapy,
  • Patients must not have received chemotherapy, hormonal therapy, or Herceptin within 2 weeks of E7070 treatment start and must have recovered from any chemotherapy-related or other therapy-related toxicity at study entry,
  • Patients must not have received investigational drugs including immunotherapy, gene therapy, or other biologic therapy; antineoplastic therapy; or radiation therapy (other than required for palliation of bone pain or chest ulceration) within 2 weeks of E7070 treatment,
  • Patients must not have received prior treatment with Mitomycin C or nitrosoureas,
  • Patients must not have undergone high dose chemotherapy with hematopoietic stem cell rescue,
  • Patients must not have untreated brain metastases (Patients who have been treated for central nervous system (CNS) metastases must be asymptomatic and radiologically stable [not receiving radiation] and must not have been receiving steroids for 4 weeks prior to entry.

Patients without known CNS metastases who are symptomatic for CNS metastasis must be evaluated with a CT scan or MRI scan prior to E7070 treatment.),

  • Patients must not have had major surgery without full recovery within 4 weeks of E7070 treatment start,
  • Patients must not have pulmonary lymphatic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen,
  • Patients must not have leptomeningeal metastasis,
  • Patients must not have evidence of clinically relevant ascites or pleural effusion requiring more than one isolated paracentesis or pleurocentesis per month prior to study start,
  • Patients must not be expected to require more than one isolated paracentesis or pleurocentesis per month during the study for the treatment of clinically relevant ascites or pleural effusion,
  • Patients must not be pregnant or breast-feeding and must practice adequate contraception if not surgically sterile,
  • Patients must not have severe medically uncontrolled intercurrent illness/infection,
  • Patients must not have had unstable angina or myocardial infarction in the past 6 months,
  • Patients must not have serious cardiac arrhythmia or symptomatic congestive heart failure >= Grade II (NYHA classification),
  • Patients must not have a history of prolonged QT, QTc > 470 ms (Bazett’s correction) at entry, or history of torsade de pointes,
  • Patients must not have recent history (<= 12 months) of active or chronic viral hepatitis,
  • Patients must not have organ allografts,
  • Patients must not have known history of HIV positivity,
  • Patients must not have a history of hypersensitivity to sulfonamides,
  • Patients must not have a history of uncontrolled seizures,
  • Patients must not have had a prior malignancy, other than carcinoma in situ of the cervix or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence, or
  • Patients must not have other significant disease or disorders that, in the Investigator’s opinion, would exclude the patient from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00080197

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
Hoover, Alabama, United States
United States, Arizona
Sedona, Arizona, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Torrington, Connecticut, United States
United States, Florida
Fort Myers, Florida, United States
Ocoee, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Skokie, Illinois, United States
Urbana, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Albany, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Kettering, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Pennsylvania
Clairton, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wexford, Pennsylvania, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fredericksburg, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Tyler, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
United States, Washington
Spokane, Washington, United States
Vancouver, Washington, United States
Canada, Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
Eisai Inc.
Study Director: Sandra Silberman, M.D. Eisai Inc.

Additional Information: Identifier: NCT00080197     History of Changes
Other Study ID Numbers: E7070-A001-211
First Posted: March 25, 2004    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: October 2006

Keywords provided by Eisai Inc.:
Breast Cancer
Cancer of the Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases