Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01190982
• Date of registration: 26/08/2010
• Primary sponsor: Insys Therapeutics Inc
• Public title: Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
• Scientific title: A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer
• Date of first enrolment: March 2008
• Target sample size: 70
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01190982
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

India

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Be 18 years or older and female.

2. Have histologically or cytologically confirmed diagnosis of invasive adenocarcinoma
originating in the breast.

3. Have at least one target lesion per RECIST criteria

4. If the patient has received adjuvant or neoadjuvant taxane therapy, the patient must
not have relapsed with breast cancer within one year of completing this therapy.

5. Have received prior chemotherapy in the adjuvant or metastatic setting with an
anthracycline unless contraindicated.

6. Have no other malignancy within the past five years, except non-melanoma skin cancer,
cervical intraepithelial neoplasia (CIN), or in-situ cervical cancer (CIS).

7. Have the following hematology levels at Baseline:

- ANC greater than or equal to 1,500 x 106 cells/L;

- Platelets greater than or equal to 100 x 109 cells/L;

- Hgb greater than or equal to 90 g/L.

8. Have the following chemistry levels at Baseline:

- AST (SGOT), ALT (SGPT) less than or equal to 2.5 x ULN if no evidence of liver
metastases;

- AST (SGOT), ALT (SGPT) less than or equal to 5 x ULN if liver metastases are
present;

- Total bilirubin less than or equal to 26 micromol/L (1.5 mg/dL);

- Creatinine less than or equal to 177 micromol/L (2 mg/dL); or 24-hour

- Alkaline phosphatase less than or equal to 5 x ULN (unless bone metastasis is
present in the absence of liver metastasis).

9. Have a life expectancy of greater than or equal to 12 weeks.

10. Have an ECOG Performance status of 0-2.

11. Patients of child-bearing potential must agree to use acceptable contraceptive
methods (e.g., double barrier) during treatment.

12. Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee -approved written informed consent
form prior to receiving any study related procedure.

Exclusion Criteria:

1. Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal
brain metastases; any leptomeningeal metastases; or asymptomatic untreated
intraparenchymal brain metastases requiring treatment.

2. Patient has received more than 1 prior treatment with a non-taxane agent in the
metastatic setting.

3. The only evidence of metastasis is lytic or blastic bone metastases or pleural
effusion or ascites.

4. Patient has a known infection with human immunodeficiency virus or active viral
hepatitis.

5. Patient has active heart disease including myocardial infarction or congestive heart
failure within the previous 6 months, symptomatic coronary artery disease, or
uncontrolled arrhythmias.

6. Any condition which in the Investigator's opinion deems the patient an unsuitable
candidate to receive study drug (e.g., uncontrolled bleeding or bleeding diathesis).

7. Any active infection requiring parenteral or oral antibiotics.

8. The patient receives treatment with any:

- Hormonal or other non-investigational agent therapy within 2 weeks prior to
first dose of study drug;

- Herceptin, mitomycin, or nitrosoureas therapy within 6 weeks prior to first
dose;

- Chemotherapy (except for palliative bisphosphonate therapy for bone pain which
can be administered as clinically indicated) within 4 weeks prior to first dose
study drug;

- Investigational drug or immunotherapy within 4 weeks prior to first dose study
drug;

- Concurrent radiation therapy (except for palliative radiotherapy for

- Radiation therapy within 4 weeks prior to first dose of study drug.

9. Patient has pre-existing peripheral neuropathy of NCI-CTCAE Grade >1.

10. Patient has received paclitaxel, docetaxel, or Abraxane because of metastatic
carcinoma.

11. Known hypersensitivity to paclitaxel, Cremophor EL, or liposomes.

12. Pregnant or nursing female patients.

13. Unwilling or unable to follow protocol requirements.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: LEP-ETU

Primary Outcome(s)

Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose [Time Frame: 2 years]

Secondary Outcome(s)

LEP-ETU 275mg/m2 Induce Progression-Free Survival Assessment [Time Frame: 2 years]

Secondary ID(s)

LEP-ETU 202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors