Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Avastin; Gemcitabine; Abraxane
Intervention MeSH terms: Paclitaxel; Bevacizumab; Gemcitabine; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer

Summary:

      The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will
      increase the progression-free survival (PFS) in patients with first line metastatic breast
      cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with
      definable metastatic disease, 6 or more months after primary treatment.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients must either be:

               -  treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified)
                  metastatic (Stage IV) breast cancer, or

               -  HER2/neu-negative patients with metastasis diagnosed 6 or more months after
                  completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).

          2. No previous chemotherapy regimen for metastatic breast cancer.

          3. 18 years of age or older.

          4. Measurable disease as defined by RECIST criteria or evaluable disease.

          5. Eastern Cooperative Oncology Group (ECOG) 0-1.

          6. Life expectancy greater than 3 months.

          7. For female (or male) patients, either pre- or post-menopausal, surgically sterilized,
             or willing to use an acceptable method of birth control for the duration of the study

          8. Provide written informed consent before any study-related procedure not part of normal
             medical care is conducted

          9. Willing and able to comply with the protocol requirement

         10. Laboratory parameters as follows:

               -  Neutrophils: 1.5 x109/L or greater

               -  Platelets: 100 x109/L or greater

               -  Hemoglobin: ≥ 9.0 g/dL

               -  Serum Creatinine: ≤ 1.5mg/dL

               -  Bilirubin: ≤ ULN, except when caused by metastatic disease

               -  Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times the upper
                  limit of the normal range (ULN) except when caused by metastatic disease

               -  Urine protein creatinine (UPC) ratio < 1.0 at screening.

        Exclusion Criteria

          1. Previous treatment with gemcitabine.

          2. History of Gastrointestinal Bleeding in the previous 3 months.

          3. Chemotherapy within 4 weeks prior to enrollment.

          4. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks
             prior to enrollment.

          5. Any major surgery within 4 weeks prior to enrollment.

          6. Presence of central nervous system or brain metastases.

          7. Urine protein: creatinine ratio ≥ 1.0 at screening.

          8. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or
             diastolic blood pressure > 100 mmHg on antihypertensive medications).

          9. A prior history of hypertensive crisis or hypertensive encephalopathy.

         10. Peripheral neuropathy > grade I.

         11. Clinical AIDS or known positive HIV serology

         12. No concurrent clinically evident malignancy is allowed except inactive non-melanoma
             skin cancer and inactive cervical cancer diagnosed or other cancer for which the
             patient has been disease-free for five years.

         13. Unstable angina.

         14. New York Heart Association (NYHA) Grade II or greater congestive heart failure

         15. History of myocardial infarction within 6 months.

         16. History of stroke within 6 months.

         17. Clinically significant peripheral vascular disease.

         18. Evidence of bleeding diathesis or coagulopathy

         19. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to enrollment, anticipation of need for major surgical procedure during the
             course of the study.

         20. Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to enrollment.

         21. Pregnant (positive pregnancy test) or lactating.

         22. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to enrollment

         23. Serious, non-healing wound, ulcer, or bone fracture

         24. Inability to comply with study and/or follow-up procedures

         25. Participants with serious medical or psychiatric illness that would render
             chemotherapy unsafe are ineligible.

         26. Participants cannot have been in another experimental drug study other than a
             Bevacizumab cancer study within 4 weeks of the first infusion of these study
             medications.