Clinical Trials /

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Patients With Stage I-II HER2/Neu Positive Breast Cancer After Surgery

NCT02654119

Description:

This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Cyclophosphamide</span>, <span class="go-doc-concept go-doc-intervention">Paclitaxel,</span> and <span class="go-doc-concept go-doc-intervention">Trastuzumab</span> in Treating Patients With Stage I-II <span class="go-doc-concept go-doc-biomarker">HER2</span>/Neu Positive Breast Cancer After Surgery

Title

  • Brief Title: Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Patients With Stage I-II HER2/Neu Positive Breast Cancer After Surgery
  • Official Title: A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With Trastuzumab in Stage I-II HER2/Neu Positive Breast Cancer Patients
  • Clinical Trial IDs

    NCT ID: NCT02654119

    ORG ID: 318-15

    NCI ID: NCI-2015-01879

    Trial Conditions

    HER2 Positive Breast Carcinoma

    Stage IA Breast Cancer

    Stage IB Breast Cancer

    Stage IIA Breast Cancer

    Stage IIB Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Cyclophosphamide (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719 Treatment (cyclophosphamide, paclitaxel, trastuzumab)
    Paclitaxel Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat Treatment (cyclophosphamide, paclitaxel, trastuzumab)

    Trial Purpose

    This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and
    trastuzumab work when given after surgery in treating patients with stage I-II human
    epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast
    or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as
    cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells,
    either by killing the cells, by stopping them from dividing, or by stopping them from
    spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of
    tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel and trastuzumab after
    surgery may help prevent the cancer from coming back.

    Detailed Description

    PRIMARY OBJECTIVES:

    I. To determine the toxicities and ability to complete the planned treatment of a dose-dense
    regimen of cyclophosphamide and paclitaxel with trastuzumab in subjects with newly diagnosed
    stage I-II HER2/neu positive breast cancer.

    II. To estimate recurrence free survival of a dose-dense regimen of cyclophosphamide and
    paclitaxel with trastuzumab in subjects with newly diagnosed stage I-II HER2/neu positive
    breast cancer.

    OUTLINE:

    SYSTEMIC THERAPY: Patients receive cyclophosphamide intravenously (IV) over 1 hour,
    paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment
    repeats every 14 days for 6 courses in the absence of disease progression or unacceptable
    toxicity.

    MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over
    30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of
    disease progression or unacceptable toxicity.

    Patients may undergo radiation therapy at the discretion of the radiation oncologist and
    medical oncologist and patients with estrogen/progesterone receptor positive tumors receive
    hormonal therapy as determined by the medical oncologist per standard National Comprehensive
    Care Network (NCCN) guidelines.

    After completion of study treatment, patients are followed up every 3 months for 2 years.

    Trial Arms

    Name Type Description Interventions
    Treatment (cyclophosphamide, paclitaxel, trastuzumab) Experimental SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines. Cyclophosphamide, Paclitaxel

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer

    - 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)

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    - Absolute neutrophil count greater than or equal to 1,500/mcl

    - Platelet count equal to or greater than 150,000/mcl

    - Hemoglobin > 11 gm/dl

    - 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

    - Able to give informed consent

    - All included subjects must have normal cardiac function as defined by an ejection
    fraction of > 50% by echocardiogram

    - Able to return for treatment and follow-up on the specified days

    Exclusion Criteria:

    - Prior malignancy; except for adequately treated basal cell or squamous cell skin
    cancer or noninvasive carcinomas

    - Subjects with pre-existing grade II peripheral neuropathy

    - History of previous chemotherapy

    - Stage IV or metastatic breast cancer

    - Pregnant or nursing women

    - Inability to cooperate with treatment protocol

    - No active serious infections or other conditions precluding chemotherapy

    - Any comorbidity or condition which, in the opinion of the investigator, may interfere
    with the assessments and procedures of this protocol e.g. unstable angina, myocardial
    infarction within 6 months, severe infection, etc.

    - Known hypersensitivity to any component of required drugs in the study

    - Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type
    A, B or C or active hepatitis

    - 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
    electrocardiographic (ECG) abnormality at screening has to be documented by the
    investigator as not medically relevant

    Minimum Eligible Age: 19 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Incidence of grade 3/4 cardiotoxicity, graded according to the NCI CTCAE v4.03

    Incidence of grade 3/4 nausea/vomiting, graded according to the NCI CTCAE v4.03

    Incidence of inability to complete treatment, defined as a patient that requires a lower dose of therapy (defined as dose lowered by 50%), or a postponement of scheduled treatment of longer than 28 days, or discontinuation of treatment for any reason

    Incidence of neutropenia, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03

    Incidence of paclitaxel-related neuropathy, graded according to the NCI CTCAE v4.03

    Recurrence free survival (RFS)

    Secondary Outcome Measures

    Trial Keywords