Status:
UNKNOWN
A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Lead Sponsor:
Bionovo
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The investigators' proposed phase 2 clinical trial will be an open-label, non-randomized study among 80 women with metastatic breast cancer. The study treatment period will be up to twelve months and ...
Eligibility Criteria
Inclusion
- Women 18 years or older.
- Histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer.
- Clinical evidence of metastatic (stage IV) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings.
- Availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (Status on the most recent biopsy where ER/PR status was documented will be used to determine hormone receptor status for stratification).
- At least one measurable disease site defined by RECIST criteria, with measurement made within 30 days of beginning study therapy. (Non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. For lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation).
- No more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (Participants may have received any number of exogenous hormone therapies for Stage IV disease and/or adjuvant therapy).
- Life expectancy of \>12 weeks.
- Eastern Cooperative Oncology Group performance status \<2.
- Women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. Acceptable methods of contraception are as follows:
- Intrauterine device (IUD)
- Hormonal birth control
- Tubal ligation
- Partner's vasectomy
- Latex condom
- Diaphragm
- Cervical cap
- Adequate organ and marrow function measured within 14 days of study treatment as defined below:
- Absolute neutrophil count \>1,500 cells/mm3 Platelets \>100,000 cells/mm3 Hemoglobin \>10 g/dL Total bilirubin \<1.5 mg/dL AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal or \<5 X normal with documented liver metastasis Alkaline Phosphatase \<3 X institutional upper limit of normal or \<5 X normal with documented liver or bone metastasis Serum creatinine \<1.5 mg/dL or Creatinine clearance \>60 mL/min/1.73 m2 for participants with serum creatinine levels above institutional normal.
Exclusion
- \-
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00907959
Start Date
January 1 2012
End Date
July 1 2015
Last Update
February 8 2012
Active Locations (1)
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1
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030