Description:
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-.
Title
- Brief Title: A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
- Official Title: A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
BZL-101-003
- NCT ID:
NCT00907959
Conditions
Interventions
Purpose
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-.
Trial Arms
Name | Type | Description | Interventions |
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Eligibility Criteria
Inclusion Criteria:
1. Women 18 years or older.
2. Histologically confirmed diagnosis of breast cancer based on pathology report of
primary, regional or metastatic breast cancer.
3. Clinical evidence of metastatic (stage IV) involvement other than bone only metastasis
based on the investigator's clinical and/or radiographic findings.
4. 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).
5. 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).
6. 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).
7. Life expectancy of >12 weeks.
8. Eastern Cooperative Oncology Group performance status <2.
9. 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:
1. Intrauterine device (IUD)
2. Hormonal birth control
3. Tubal ligation
4. Partner's vasectomy
5. Latex condom
6. Diaphragm
7. Cervical cap
10. 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 Criteria:
-
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The primary outcomes of the Phase 2 trial will be safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and tumor response rate defined by new RECIST criteria 1.1. |
Time Frame: | Monthly |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Bionovo |
Last Updated
February 8, 2012