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A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 For Metastatic Breast Cancer.


Inclusion Criteria:

- Women 18 years or older

- Histologically confirmed breast cancer

- Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis)

- Availability of estrogen and progesterone receptor status

- At least one measurable disease site defined by RECIST criteria, 30 days prior to
study therapy

- For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast
cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic
breast cancer

- Life expectancy ≥ 12 weeks

- Eastern Cooperative Oncology Group performance status ≤2

- Women of child bearing potential must agree to 2 forms of contraception during the
course of the trial.

Key Exclusion Criteria:

- Inability to understand/unwillingness to sign a written informed consent

- Any significant side effects related to prior chemo, radiation, biology or hormonal
therapy that did not resolve in the judgment of the investigator

- Currently using an investigational agent

- Clinically significant gastrointestinal abnormalities

- Currently using coumadin at therapeutic doses or within 2 weeks of taking study

- Concurrent palliative radiation or anti-cancer treatment

- Women who report pregnancy, are breast-feeding or have a positive pregnancy test

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)

Outcome Description:

Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0

Outcome Time Frame:


Safety Issue:


Principal Investigator

Deborah Grady, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Bionovo
  • BZL101
  • Chinese Herbs
  • Breast Neoplasms