Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Albumin-bound paclitaxel; Carboplatin; Herceptin®
Intervention description: Administered by intravenous infusion.; Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.; Administered by IV infusion
Intervention MeSH terms: Paclitaxel; Carboplatin; Trastuzumab; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Breast Cancer

Summary:

      This trial will treat patients with advanced breast cancer with a new anti-cancer medicine
      used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel
      (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a
      weekly basis and may continue on therapy as long as their condition improves and drug
      toxicity is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed adenocarcinoma of the breast

          -  Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2
             (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ
             hybridization (FISH)+

          -  Stage IV disease

          -  Measurable disease

          -  At least 3 weeks since prior cytotoxic chemotherapy

          -  At least 4 weeks since radiotherapy with full recovery

          -  At least 4 weeks since major surgery with full recovery

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  At least 18 years old

          -  Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L

          -  Platelets at least 100 x 10^9 cells/L

          -  Hemoglobin at least 9 g/dL

          -  Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper
             limit normal

          -  Alkaline Phosphatase less than 1.5X upper limit normal

          -  Creatinine less than 1.5 gm/dL

          -  Normal left ventricular ejection fraction

          -  Negative pregnancy test

          -  Agree to use method to avoid pregnancy

          -  Informed Consent is obtained

        Exclusion Criteria:

          -  Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year
             since Taxane and Herceptin treatment.

          -  Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2

          -  Concurrent immunotherapy or hormonal therapy

          -  Parenchymal brain metastases, if present, must be documented to be clinically and
             radiographically stable for at least 6 months after treatment

          -  Serious intercurrent medical or psychiatric illness, including serious active
             infection

          -  History of congestive heart failure

          -  History of other malignancy within the last 5 years which could affect the diagnosis
             or assessment of breast cancer

          -  Patients who have received an investigational drug within the previous 3 weeks

          -  Patient is currently enrolled in another clinical study receiving investigational
             therapies

          -  Pregnant or nursing women