Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pre operativeTrastuzumab; ABI-007 (Abraxane); Vinorelbine
Intervention description: Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion.
As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.; ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8).; Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20).
Intervention MeSH terms: Albumin-Bound Paclitaxel; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor
      2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with
      trastuzumab before having breast surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed invasive breast carcinoma.

          -  Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.

          -  3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.

          -  Patients must have measurable disease as defined by palpable lesion with both
             diameters greater than or equal to 1 cm measurable with caliper and/or a positive
             mammogram or ultrasound with at least one dimension greater than or equal to 1 cm.
             Bilateral mammogram and clip placement is required for study entry. Baseline
             measurements of the indicator lesions must be recorded on the patient registration
             form. To be valid for baseline, the measurements must have been made within the 14
             days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.

          -  ECOG performance status 0 to 2 within 14 days of study entry.

          -  Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or
             echocardiography.

          -  Must be 18 years of age or older.

          -  Women or men of childbearing potential must use a reliable and appropriate
             contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months
             to be considered of non-childbearing potential.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.

        Exclusion Criteria:

          -  Evidence of disease outside the breast or chest wall, except ipsilateral axillary
             lymph nodes.

          -  Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast
             cancer. Patients with history of DCIS are eligible if they were treated with surgery
             alone.

          -  Medical, psychological, or surgical condition which the investigator feels might
             compromise study participation.

          -  Pregnant or lactating women are not eligible.

          -  Patients with history of previous or current malignancy at other sites with the
             exception of adequately treated carcinoma in situ of the cervix or basal or squamous
             cell carcinoma of the skin. Patients with a history of other malignancies who remain
             disease free for greater than five years are eligible.

          -  Evidence of sensory and/or peripheral neuropathy.

          -  Serious, uncontrolled, concurrent infections.

          -  Major surgery within 4 weeks of the start of study treatment without complete
             recovery.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.