Protocol Title

Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer (425-07)

Description

More than 60% of the drugs used to treat breast cancer are obtained from natural substances. Drugs made from plants have been used for centuries to treat cancer and cancer-related symptoms. With the exception of the drug class called taxanes made from the Pacific yew tree, botanical agents have not been tested in clinical trials to assess their safety and effectiveness in treating breast cancer. BZL101 is a Chinese medicine extract made from the herb Scutellaria Barbata or Chinese skullcap. Previously a water containing extract of Chinese skullcap was shown to inhibit the growth of breast cancer cells in a test tube.

In a previous phase I study, BZL101 had very limited side effects and showed encouraging activity in controlling tumor in women with metastatic breast cancer who had failed several previous treatments. The current study is being done in two parts. The purpose of the phase I portion of this study is to test the safety of BZL101 at different escalating dose levels to find the optimal dose of BZL101 to treat metastatic breast cancer. After the phase I part of the study is completed, the second part of the study (phase II) will be done to learn more about the side effects, good and bad, of BZL101and to see if BZL101 will slow down or stop the growth of metastatic breast cancer.

If a patient meets the eligibility criteria, she will take BZL101 by mouth every day for a maximum of one year. BZL101 is packaged as a powder that has to be mixed with water or another liquid.

Objectives

To learn the effects (good and bad) of treating patients with BZL101

To study whether this treatment will reduce the growth of breast cancer.

Eligibility

Patient is at least 18 years of age.

Patient has a histological diagnosis of metastatic breast cancer and has disease that can be measured on their imaging studies (CT scan, MRI, bone scan).

Patients of childbearing potential must have a negative pregnancy test and agree to use two accepted methods of non-hormonal contraception

For the phase II portion of the study, patients cannot have had more than 2 prior chemotherapy regimens for metastatic breast cancer.

Patient must have adequate organ function and meets other guidelines for eligibility as specified by the protocol.

Contact

For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.

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