Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer
Condition: Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; HER2/Neu Positive; Invasive Breast Carcinoma; Progesterone Receptor Negative; Progesterone Receptor Positive; Stage IA Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-Negative Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms
Intervention: Cyclophosphamide; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Paclitaxel; Radiation Therapy; Therapeutic Conventional Surgery; Trastuzumab
Intervention description: Given IV; Given IV; Correlative studies; Given IV; Undergo RT; Undergo mastectomy or breast conserving surgery; Given IV
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab; Albumin-Bound Paclitaxel; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well giving paclitaxel and
      cyclophosphamide with or without trastuzumab before surgery works in treating patients with
      previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and
      cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may
      block tumor growth in different ways by targeting certain cells. Giving combination
      chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce
      the amount of normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with histologically proven invasive breast cancer without distant metastases; a
             clinical tumor classification of tumor size must be at least 1 cm with or without
             clinical pathologic evidence of positive nodes

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  At least one lesion that can be accurately measured in two dimensions utilizing
             mammogram, ultrasound, or magnetic resonance imaging (MRI) images to define specific
             size and validate complete clinical and pathologic response

          -  Patients who received radiation therapy > 5 years ago for malignancies other than
             breast cancer and whose radiation therapy field is not overlapping with the 20%
             isodose line of current radiation field are eligible, provided that radiation therapy
             was completed > 5 years ago and that there is no evidence of the second malignancy at
             the time of study entry

          -  Absolute neutrophil count greater than or equal to 1,500/mcl

          -  Platelet count equal to or greater than 150,000/mcl

          -  Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)

          -  Total bilirubin equal to or less than 1.5 times the ULN

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than
             1.5 times the ULN

          -  Creatinine less than 1.5 times the ULN

          -  All included patients must have normal cardiac function as defined by an ejection
             fraction of >= 50% and no decrease in wall motion by echocardiogram

          -  The patient must be aware of the neoplastic nature of his/her disease and willingly
             provide written, informed consent after being informed of the procedure to be
             followed, the experimental nature of the therapy, alternatives, potential benefits,
             side-effects, risks, and discomforts

          -  Women of reproductive potential must be non-pregnant and non-nursing and must agree to
             employ an effective barrier method of birth control throughout the study and for up to
             6 months following treatment

          -  Women of child-bearing potential must have a negative pregnancy test within 7 days of
             initiating study; (no childbearing potential is defined as age 55 years or older and
             no menses for two years or any age with surgical removal of the uterus and/or both
             ovaries)

        Exclusion Criteria:

          -  Any patient with inflammatory breast cancer or stage IV or confirmed metastatic
             disease

          -  Patients who have had any prior chemotherapy, or endocrine therapy for the treatment
             of breast cancer or any other cancer

          -  Patients who cannot undergo surgery

          -  Patients with a known or documented anaphylactic reaction or allergy to any of
             chemotherapy agents used in this protocol, or to antiemetics appropriate for
             administration in conjunction with protocol-directed therapy

          -  Uncontrolled inter-current illness including, but not limited to ongoing or active
             infection requiring intravenous antibiotics, symptomatic congestive heart failure,
             unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might
             jeopardize the ability of the patient to receive the therapy program outlined in this
             protocol with reasonable safety

          -  Patients with preexisting grade II peripheral neuropathy

          -  Pregnant and nursing women are excluded from this study

          -  Patients with prior malignancy will be excluded except for adequately treated basal
             cell or squamous cell skin cancer, adequately treated noninvasive carcinomas

          -  Inability to cooperate with treatment protocol

          -  Patients with known human immunodeficiency virus (HIV) infection, infectious
             hepatitis, type A, B or C, active hepatitis, or hepatic insufficiency

          -  Patients may not be receiving or have received any other investigational agents
             during/or within 1 month prior

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form

          -  Myocardial infarction within 6 months prior to enrollment or has New York Heart
             Association (NYHA) class III or IV heart failure uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities; prior to study entry, any
             electrocardiogram (ECG) abnormality at screening has to be documented by the
             investigator as not medically relevant