Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ABI-007; Docetaxel
Intervention description: ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.; Docetaxel dosed q3w at 100 mg/m^2
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic breast cancer, nab paclitaxel, docetaxel,

Summary:

      This was an open-label study conducted comparing the toxicity and antitumor activity of
      ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients had to meet the following criteria to be eligible for the study:

          1. Pathologically confirmed adenocarcinoma of the breast.

          2. No prior chemotherapy for metastatic breast cancer.

          3. Stage IV disease.

          4. Measurable disease (must have been ≥ 2.0 cm, except for pulmonary lesions that were
             well documented on CT scan that were ≥ 1.0 cm).

          5. At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered
             from all acute effects of such therapy.

          6. At least 4 weeks since radiotherapy, with full recovery. The measurable disease was
             completely outside the radiation portal or there was radiologic or clinical exam proof
             of progressive disease within the radiation portal.

          7. At least 4 weeks since major surgery, with full recovery.

          8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          9. Age ≥18 years.

         10. Patient had the following blood counts at Baseline:

               -  Absolute neutrophil count (ANC) ≥1.5*10^9 cells/L

               -  Platelets ≥100*10^9 cells/L

               -  Hemoglobin (Hgb) ≥9 g/dL.

         11. Patient had the following baseline blood chemistry levels:

               -  Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT
                  [SGPT])≥2.5x upper limit of normal (ULN) range

               -  Total bilirubin normal

               -  Alkaline phosphatase ≥2.5x ULN (unless bone metastasis is present in the absence
                  of liver metastasis)

               -  Creatinine ≥1.5 mg/dL.

         12. Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common
             Terminology Criteria for Adverse Events (CTCAE).

         13. If female of childbearing potential, pregnancy test was negative (within 72 hours of
             the first dose of study drug).

         14. If fertile, the patient agreed to use an effective method to avoid pregnancy for the
             duration of the study.

         15. Informed consent had been obtained.

        Exclusion Criteria:

        Patients who met any of the following criteria were excluded from the study:

          1. Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for
             metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least
             one year should have transpired since completion of taxane regimen.

          2. Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior
             neo-adjuvant or adjuvant therapy but not for metastatic disease.

          3. Concurrent immunotherapy or hormonal therapy for breast cancer.

          4. Parenchymal brain metastases, unless documented to be clinically and radiographically
             stable for at least 6 months after treatment.

          5. Serious intercurrent medical or psychiatric illness, including serious active
             infection.

          6. History of class II-IV congestive heart failure.

          7. History of other malignancy within the last 5 years which could affect the diagnosis
             or assessment of breast cancer.

          8. Patients who had received an investigational drug within the previous 3 weeks.

          9. Patient was enrolled in a different clinical study in which investigational procedures
             were performed or investigational therapies were administered. Also, a patient was not
             permitted enroll in such clinical trials while participating in this study.

         10. Pregnant or nursing women

         11. Patients with prior hypersensitivity to either Taxol or Taxotere.