A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
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
7. Cervical cap
10. Adequate organ and marrow function measured within 14 days of study treatment as
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.