Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores
Condition: Breast Neoplasms; Breast Cancer; Cancer of the Breast
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Docetaxel with Cytoxan; Dexamethasone
Intervention description: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.; Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
Intervention MeSH terms: Dexamethasone; Docetaxel; Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Tumors, Breast; Cancer of the breast

Summary:

      The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your
      breast tumor and allow you to preserve your breast or have less extensive surgery on your
      breast. Additionally, by receiving chemotherapy before surgery, the investigators will be
      able to determine if your cancer is responsive to chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Histologically or cytologically confirmed breast carcinoma.

          -  Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], cM0).

          -  No evidence of disease outside the breast or chest wall, except ipsilateral axillary
             or internal mammary lymph nodes.

          -  Pre-treatment biopsy with the following characteristics:

               -  Hormone receptor-positive cancer as defined as ER and/or progesterone receptor
                  (PR)-positive by standard immunohistochemistry (IHC)

               -  HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be fluorescence in situ
                  hybridization [FISH] non-amplified)

               -  Recurrence score ≥ 25 using Oncotype DX 21-gene assay

          -  Patients must have measurable disease as defined by palpable lesion with both
             diameters ≥ 1cm measurable with caliper or a positive mammogram or ultrasound with at
             least one dimension ≥ 1cm. 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 if palpable. If not palpable, a mammogram or
             MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2
             months prior to study entry. If clinically indicated, xrays and scans must be done
             within 28 days of study entry.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

          -  No prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for
             breast cancer.

          -  Adequate organ function within 14 days of study entry:

               -  Bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mm³, Hgb > 8.0 g/dl,
                  and platelet count ≥ 100,000/mm³.

               -  Hepatic function: total bilirubin < upper limit of normal (ULN). Serum glutamic
                  oxaloacetic transaminase (SGOT)(AST) or serum glutamic pyruvic transaminase
                  (SGPT)(ALT) and alkaline phosphatase ≤ 1.5 x ULN.

               -  Renal function: calculated creatinine clearance (CrCl) ≥ 30 mL/min using the
                  Cockroft Gault equation.

          -  Patients must be at least 18 years of age.

        Exclusion Criteria:

          -  Pregnant or lactating women are not eligible. Women of childbearing potential must
             have a negative serum pregnancy test completed within 7 days of study entry, and use
             an appropriate form of birth control throughout the trial period.

          -  No medical, psychological or surgical condition which the investigator feels might
             compromise study participation.

          -  No patients with history within the last 5 years 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.

          -  No evidence of peripheral or sensory neuropathy.

          -  Patients with a history of severe hypersensitivity reaction to docetaxel or other
             drugs formulated with polysorbate 80 are excluded from participation.

          -  No serious, uncontrolled, concurrent infection(s).

          -  No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
             coronary artery disease and cardiac arrhythmias not well controlled with medication)
             or myocardial infarction within the last 12 months prior to study entry.

          -  No major surgery within 28 days of study entry.

          -  No evidence of central nervous system (CNS) metastases.