Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Doxorubicin; Cyclophosphamide; Paclitaxel; Carboplatin; GM-CSF; Trastuzumab
Intervention description: 60 mg/m2 IV, bolus once every 14 days x 2-4 cycles; 600 mg/m2 IV once every 14 days x 2-4 cycles; 80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose; Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose; 250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide; AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Doxorubicin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with
      GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer
      paclitaxel and carboplatin weekly for a total of 12 doses with one week rest after every 3
      weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH
      (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin
      and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast
      cancer with improved clinical outcome.
    

Eligibility criteria:

        Eligibility Criteria:

          1. Patients must be women with a histologically confirmed diagnosis of locally advanced
             or inflammatory breast carcinoma. Histologic confirmation shall be by either core
             needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer
             is documented.

          2. Patients must meet one of the criteria defined below (indicate one):

             a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily
             unresectable by an experienced breast surgeon; or otherwise deemed appropriate
             candidates for neoadjuvant treatment.

             b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.

          3. Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment
             must be performed within 90 days prior to registration.

          4. Patients with the clinical diagnosis of congestive heart failure or angina pectoris
             are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple
             Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to
             registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular
             Ejection Fraction (LVEF) % must be greater than the institutional lower limit of
             normal.

          5. Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of
             normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic
             pyruvic transaminase (SGPT) ≤ 2x the institutional upper limit of normal. These tests
             must have been performed within 90 days prior to registration.

          6. Patients must have an Absolute neutrophil count (ANC) of ≥ 1,500/μl and a platelet
             count of ≥ 100,000/μl. These tests must have been performed within 90 days prior to
             registration.

          7. Patients must have a performance status of 0-2 by Zubrod criteria

          8. Pregnant or nursing women may not participate due to the possibility of fetal harm or
             of harm to nursing infants from this treatment regimen. Women of reproductive
             potential may not participate unless they have agreed to use an effective
             contraceptive method. A urine pregnancy test is required for women of childbearing
             potential.

          9. All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines.