Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
Intervention description: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; adenocarcinoma of the breast; cardiac safety; Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center

Summary:

      HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a
      protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard
      treatments for this type of cancer will help some people, but there is a moderate to high
      chance that your cancer may come back.

      The purpose of this study is to see if a new regimen will be effective in preventing cancer
      from coming back. This is a phase II trial. In this trial, patient get a drug regimen that
      has been tested in small groups of people to see what dose is safe. Researchers now wish to
      see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking
      at short-term side effects and risks of the drug. All of the drugs on this regimen can affect
      the heart which can be a serious side effect. The drugs affect on heart function is a primary
      focus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adenocarcinoma breast cancer

          -  ECOG performance status of 0 or 1

          -  peripheral neuropathy less than or equal to 1

          -  discontinued hormonal therapy as a chemoprevention while onstudy

          -  LVEF by MUGA > 55%?

          -  Absolute neutrophil count (ANC)> 1000/µL)

          -  platelet count > 100,000/µL)

          -  SGOT OR SGPT < 92.5 units/L

        Exclusion Criteria:

          -  Stage IV breast cancer

          -  any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast
             cancer

          -  pregnant or lactating patients

          -  active second malignancy, other than adequately treated non-melanoma skin cancers or
             in situ cervical cancer

          -  previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or
             other drugs formulated in Cremophor EL?

          -  unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or
             calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical
             therapy, or a history of a myocardial infarction within 12 months

          -  psychiatric illness that prevents her from understanding the nature of this study and
             complying with protocol requirements?

          -  active, unresolved infections

          -  sensitivity to E. coli derived proteins

          -  prior chemotherapy with an anthracycline

          -  prior Herceptin therapy