ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Intervention description: 1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle; 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin
      Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine
      works in treating women with metastatic breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed invasive breast cancer

             - Clinical evidence of metastatic disease

             + No bone metastases or other non-measurable disease as the only evidence of
             metastasis

          -  Measurable disease, defined as at least 1 measurable lesion

             - The following are considered non-measurable disease:

               -  Small lesions (< 2 cm)

               -  Bone lesions

               -  Leptomeningeal disease

               -  Ascites

               -  Pleural or pericardial effusions

               -  Inflammatory breast disease

               -  Lymphangitis cutis or pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

          -  HER2(human epidermal growth factor receptor 2)-positive disease allowed provided
             patient has received prior treatment with trastuzumab

          -  No evidence of active brain metastasis, including leptomeningeal involvement

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over Sex

          -  Female Menopausal status

          -  Not specified Performance status

          -  ECOG 0-1 Life expectancy

          -  At least 12 weeks Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL Hepatic

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN Renal

          -  Creatinine ≤ 1.5 mg/dL Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 30 days after
             completion of study treatment

          -  No pre-existing peripheral neuropathy > grade 1

          -  No other clinically significant illness or significant medical condition that would
             preclude study participation

          -  No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an
             injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or
             agents that are chemically similar to study drugs

          -  No serious medical risk factors involving any of the major organ systems that would
             preclude study participation

          -  No active stage III or IV invasive non-breast malignancy within the past 5 years

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics Chemotherapy

          -  No more than 1 prior adjuvant chemotherapy regimen

          -  No prior chemotherapy for metastatic disease

          -  At least 6 months since prior adjuvant or neoadjuvant taxane

          -  More than 2 weeks since prior cytotoxic chemotherapy

          -  Prior neoadjuvant chemotherapy allowed

          -  No other concurrent chemotherapy Endocrine therapy

          -  Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed
             Radiotherapy

          -  Prior radiotherapy to target lesion allowed provided there is evidence of disease
             progression after completion of treatment

          -  More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion
             only or single-dose palliative radiotherapy

          -  No concurrent radiotherapy Surgery

          -  Not specified Other

          -  More than 2 weeks since prior investigational drugs

          -  No concurrent participation in another clinical trial that is studying investigational
             procedures or therapies

          -  Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation
             of pain or lytic lesions from breast cancer