Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer
Condition: Early Stage Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel; Neulasta
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Early Stage Breast Cancer

Summary:

      This research study is testing the safety and feasibility of delivering the 4 cycles of
      'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte
      Colony-stimulating Factor (G-CSF) support. The research study is for participants who have
      early stage breast cancer and have been recommended to receive a standard chemotherapy
      regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a
      "dose-dense" fashion to prevent recurrences.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed Stage I-III breast cancer
             (as defined by the revised, American Joint Committee on Cancer 7th edition criteria)
             and be at sufficient risk for tumor recurrence. Staging studies to exclude metastatic
             disease are not required in asymptomatic patients. However, patients with findings
             considered suspicious for metastatic disease on any staging studies that are obtained
             need to be evaluated to exclude stage IV breast cancer.

          -  Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant
             chemotherapy with dose dense AC and T.

          -  Age ≥ 18 years and < 65 at the time of informed consent.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.

          -  Any grade 3 or clinically significant grade 2 treatment-related non-hematological
             toxicity must be resolved to grade 1 before retreatment with chemotherapy (with
             exception of alopecia)

          -  Laboratory Evaluations:

               -  Adequate blood marrow function defined as:

                    -  Absolute neutrophil count (ANC) ≥1500 µL

                    -  Hemoglobin ≥9.0 g/dl

                    -  Platelets ≥100,000/mm3

               -  Adequate hepatic function defined as:

                    -  Total bilirubin ≤ 1.2 institutional upper limit of normal (ULN)

                    -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
                       phosphatase ≤ 1.5 X upper limit normal (ULN)

               -  Adequate renal function defined as:

                  --- Serum creatinine ≤ 1.5 X ULN

               -  Premenopausal women (including women who have had a tubal ligation and for women
                  less than 12 months after the onset of menopause) must have a negative serum
                  pregnancy test.

          -  Patients with risk factors for Hepatitis B or C should be tested (anti-hepatitis C
             virus (HCV) antibody, hepatitis B surface antigen [HBsAg] or Hepatitis B core
             antibody). Risk factors include: history of unprotected sexual intercourse,
             intravenous drug use, or originally from endemic regions. If infection is suspected,
             hepatitis B virus (HBV) DNA and HCV RNA should be requested as appropriate.

          -  Note: Patients with positive Hepatitis B or C serologies without known active disease
             must meet the eligibility requirements for ALT, AST, total bilirubin, and alkaline
             phosphatase and must have a normal international normalized ratio (INR) on at least
             two consecutive occasions, separated by at least 1 week, within the 30 day screening
             period.

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have received previous cytotoxic chemotherapy including an AC-T regimen
             or previous therapeutic radiation therapy for any reason in the last 5 years. Because
             of possible limitations in bone marrow reserve, patients with such prior treatments
             are not appropriate candidates for this trial. Patients who have had prior hormonal
             therapy (for instance, tamoxifen for prevention of breast cancer) are eligible.
             Patients who have participated in a window study (treatment with an investigational
             agent prior to surgery for ≤2 weeks) are eligible but must have discontinued the
             investigational agent at least 14 days before enrollment.

          -  Participants who are receiving any other investigational agents

          -  Have had at least one prior episode of fever and neutropenia (ANC< 500/mm3 or expected
             to fall below < 500/mm3) during AC.

          -  Patients taking lithium.

          -  Patients receiving chronic treatment with oral steroids or another immunosuppressive
             agent (excluding steroids as part of the chemotherapy pre-medication or emetic
             medication).

          -  Known HIV-positive individuals or with any immunodeficiency status.

          -  Patients with history of hematologic disease, including myelodysplasia or bone marrow
             malignancies.

          -  History of allergic reaction attributed to compounds of similar chemical or biologic
             composition to Paclitaxel, which cannot be managed by premedication.

          -  Currently pregnant or breast-feeding.

          -  Uncontrolled intercurrent illness including, not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements or other significant diseases or disorders that, in the
             investigator's opinion, would exclude the subject from participating in the study.