A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Status unconfirmed · Phase 2
Conditions studied: Metastatic Breast Cancer
In brief
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 enrollment will be open at 10-15 clinical sites in the United States. In this Phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone receptor negative tumors will be enrolled and treated with BZL101 20 grams/day (10 grams BID). Hormone receptor positive will be defined as estrogen receptor (ER)+ and progesterone receptor (PR)+, ER+ and PR-, or ER- and PR+. Hormone receptor negative will be defined as ER- and PR-.
Key facts
- Study ID
- NCT00907959
- Run by
- Bionovo
- People needed
- 80
- Starts
- 2012-01-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2012-02-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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