Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: docetaxel; protein expression analysis; laboratory biomarker analysis; biopsy; conventional surgery; neoadjuvant therapy
Intervention description: Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles; protein expression analysis; laboratory biomarker analysis; biopsy; conventional surgery; neoadjuvant therapy
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: inflammatory breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and
      pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant
      docetaxel therapy.

      PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve
      the clinical and pathologic complete response rate (pCR) and safety profile of single agent
      neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with
      single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel
      (either by repeat biopsy or definitive surgery).
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion:

          -  Histologically or cytologically confirmed invasive carcinoma of the breast by core
             biopsy

          -  Tumor ≥ 2 cm in greatest dimension(may be either node positive or node negative
             disease

          -  Patients with non-metastatic breast cancer who are in the judgment of the treating
             medical oncologist considered to be of sufficiently high risk to warrant adjuvant
             chemotherapy

               -  Patients with internal mammary, supraclavicular and/or axillary node involvement
                  are eligible. Patients with inflammatory breast cancer are eligible

               -  Patients with T0 disease but palpable and measurable adenopathy are eligible for
                  this trial. All sites of disease should be noted and followed

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Menopausal status not specified

          -  Female ≥ 18 years old

          -  Absolute neutrophil count ≥ 1,000/mm^3

          -  Hemoglobin ≥ 8 g/dL

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:

               -  AP normal AND AST or ALT ≤ 5 times ULN

               -  AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

               -  AP ≤ 5 times ULN AND AST or ALT normal

          -  Women of child-bearing potential, must have a negative serum pregnancy test and must
             use effective contraception for the duration of the study and for at least 6 months
             after completion of study treatment

          -  Patients with prior malignancies are eligible if they have been disease free for ≥ 5
             years. Patients with curative treatment of non-melanomatous skin cancer, carcinoma in
             situ of the cervix, contralateral DCIS treated with mastectomy are eligible even if it
             is diagnosed in < 5 years.

        PRIOR CONCURRENT THERAPY:

          -  No prior anthracycline or taxane-based chemotherapy. Patients who received
             chemoprevention are eligible if the chemopreventive agent has been discontinued for at
             least one year prior to enrollment in the current study.

          -  At least 1 year since prior tamoxifen for breast cancer prevention

        Exclusion:

          -  Prior radiotherapy to the ipsilateral breast

               -  Patients who have had radiation to the contralateral breast are eligible

          -  Evidence of distant metastatic disease (i.e., lung, liver, bone, brain)

          -  Pregnant of breastfeeding

          -  Patients who have congestive heart failure, angina pectoris, uncontrolled cardiac
             arrhythmia, or other significant heart disease, or who have had a myocardial
             infarction within the past year

          -  Patients with > grade 1 peripheral neuropathy

          -  Patients with a history of hypersensitivity reaction to products containing
             polysorbate 80 (Tween 80)

          -  Patients receiving an investigational anticancer drug within 3 weeks of registration

          -  Patients with serious medical illness that in the judgment of the treating physician,
             places the patient at risk.