Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Condition: Inflammatory Breast Cancer; Stage IIA Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-negative Breast Cancer; Stage IIB Breast Cancer; Estrogen Receptor Negative; Progesterone Receptor Negative; HER2/Neu Negative
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: carboplatin; paclitaxel albumin-stabilized nanoparticle formulation; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Correlative studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in
      treating patients with triple negative breast cancer that is inflammatory or has spread from
      where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as
      carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells,
      either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed with locally advanced (T2 and higher with or without lymph
             node involvement), and/or inflammatory triple negative breast cancer

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control or abstinence) prior to study entry and
             for six months following duration of study participation; should a woman become
             pregnant or suspect that she is pregnant while participating on the trial, she should
             inform her treating physician immediately

          -  Tumor negative for expression of hormone receptors (< 10%) and not over-expressing
             HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by
             fluorescence in situ hybridization (FISH) or by alternative gene testing

          -  Bilirubin =< 1.5 mg/dL

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit
             of normal

          -  Alkaline phosphatase =< 2 x upper limit of normal

          -  Platelets >= 100,000 cells/mm^3

          -  Hemoglobin > 9.0 g/dL

          -  Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

          -  Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable

          -  Left ventricular ejection fraction > 50%

          -  Women of childbearing potential and sexually active males must use an effective
             contraception method during treatment and for three months after completing treatment

          -  Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test
             screening for patients of childbearing potential

          -  All subjects must have the ability to understand and the willingness to sign a written
             informed consent

          -  No prior therapies are allowed for the treatment of the newly diagnosed breast cancer;
             patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible,
             provided that they have not received prior taxanes or carboplatin as part of their
             prior treatment regimen, and that they meet all eligibility criteria

        Exclusion Criteria:

          -  Known active hepatitis B or C

          -  Known active human immunodeficiency virus (HIV)

          -  Prior breast cancer or other invasive malignancy treated within 5 years

          -  Pregnancy

          -  Neuropathy > grade 1

          -  Any other intercurrent medical/psychological problem deemed exclusionary by the
             treating physician or investigators/primary investigator (PI)

          -  Subjects will be excluded who, in the opinion of the investigator, may not be able to
             comply with the safety monitoring requirements of the study