Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Taxotere/Docetaxel; Adriamycin/Cytoxan; doxorubicin
Intervention description: Taxotere; Adriamycin/Cytoxan; AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin; Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast; Cancer; Taxotere; AC; Validation; Neoadjuvant

Summary:

      The purpose of this study is to learn if the biomarker information obtained (learned or
      received) from the earlier studies can tell us whether or not Taxotere and/or
      Adriamycin/Cytoxan can cause tumors to become smaller.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients must be female.

          2. Signed informed consent.

          3. Primary breast cancers must be of clinical and/or radiologic size >3 cm, and deemed
             surgically operable.

          4. Negative serum pregnancy test (bHCG) within 7 days of starting study, if of
             child-bearing potential.

          5. Adequate bone marrow function:

               -  Hematocrit of greater than 30%,

               -  total neutrophil count must be >1.5 x 10^9/L and

               -  platelets of > 100 x 10^9/L prior to the start of any cycle.

          6. Renal function tests:

               -  creatinine within 1.5 times of the institution's upper limit of normal (ULN).

          7. Liver function tests:

               -  Total serum bilirubin within ULN, and

               -  liver transaminases within 2.5 times ULN, and

               -  alkaline phosphatase within 5 times ULN.

          8. Electrocardiogram showing no acute ischemic changes.

          9. Performance status (World Health Organization [WHO] scale) <2.

         10. Age > 18 years.

         11. Patients older than 70 years of age should have left ventricular ejection fraction
             within ULN by multigated acquisition scan (MUGA) or 2D echocardiogram.

        Exclusion Criteria:

          1. Patients with metastatic breast cancer.

          2. Pregnancy or unwillingness to use a reliable contraceptive method in women of
             child-bearing potential.

          3. Women who are lactating or breastfeeding.

          4. Severe underlying chronic illness or disease.

          5. Peripheral neuropathy - grade 2 or greater.

          6. Patients on other investigational drugs while on study will be excluded.

          7. Severe or uncontrolled hypertension, history of congestive heart failure, acute
             myocardial infarction, or severe coronary arterial disease.

          8. Prior taxane or anthracycline chemotherapy for malignancy.

          9. Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs
             formulated with polysorbate 80.

         10. No previous or current malignancies at other sites within the last 5 years, with
             exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri
             and basal or squamous cell carcinoma of the skin.