Clinical Trials /

Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer

NCT01897441

Description:

This randomized pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, 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 interfere with the ability of tumor cells o grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients with breast cancer to study in the laboratory may help doctors learn more about how well patients will respond to treatment.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Chemotherapy</span> Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer
  • Official Title: Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy
  • Clinical Trial IDs

    NCT ID: NCT01897441

    ORG ID: 13-02-079

    NCI ID: NCI-2013-01194

    Trial Conditions

    Stage IIA Breast Cancer

    Stage IIB Breast Cancer

    Stage IIIA Breast Cancer

    Stage IIIB Breast Cancer

    Stage IIIC Breast Cancer

    Stage IV 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, CYCLOPHOSPHAMIDE, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719 Stratum A (HER2-positive disease), Stratum B (paclitaxel followed by AC), Stratum C (AC followed by paclitaxel)
    Doxorubicin Hydrochloride 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, DOXORUBICIN HYDROCHLORIDE, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex Stratum A (HER2-positive disease), Stratum B (paclitaxel followed by AC), Stratum C (AC followed by paclitaxel)
    Paclitaxel Anzatax, Asotax, Bristaxol, PACLITAXEL, Praxel, Taxol, Taxol Konzentrat Stratum A (HER2-positive disease), Stratum B (paclitaxel followed by AC), Stratum C (AC followed by paclitaxel)

    Trial Purpose

    This randomized pilot clinical trial studies chemotherapy before surgery and tissue sample
    collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such
    as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, 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 interfere with the ability of
    tumor cells o grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide,
    paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of
    tissue from patients with breast cancer to study in the laboratory may help doctors learn
    more about how well patients will respond to treatment.

    Detailed Description

    PRIMARY OBJECTIVES:

    I. To evaluate the effects of preoperative neoadjuvant paclitaxel and doxorubicin
    (doxorubicin hydrochloride)/cyclophosphamide (AC) on: senescence; invasion/motility (tumor
    microenvironment of metastasis [TMEM] and 67 kDa laminin receptor [67LR]).

    II. To create a biospecimen repository for future studies derived from patients with breast
    cancer receiving standard neoadjuvant chemotherapy.

    OUTLINE: Patients with human epidermal growth factor receptor 2 (HER2)-positive disease are
    assigned to Stratum A, and patients with HER2-negative disease are randomized to Stratum B
    or C.

    STRATUM A: Patients receive paclitaxel intravenously (IV) over 1 hour and trastuzumab IV
    over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks later, patients receive
    doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes
    every 2 weeks for 8 weeks

    STRATUM B: Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as
    in Stratum A.

    STRATUM C: Patients receive doxorubicin hydrochloride IV over 5-10 minutes and
    cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive
    paclitaxel IV over 1 hour weekly for 12 weeks.

    Patients undergo surgery 2-6 weeks after the last chemotherapy dose.

    In all arms, treatment continues in the absence of unacceptable toxicity.

    Trial Arms

    Name Type Description Interventions
    Stratum A (HER2-positive disease) Experimental Patients receive paclitaxel IV over 1 hour and trastuzumab IV over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks after the last dose of paclitaxel, patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks Cyclophosphamide, Doxorubicin Hydrochloride, Paclitaxel
    Stratum B (paclitaxel followed by AC) Experimental Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as in Stratum A. Cyclophosphamide, Doxorubicin Hydrochloride, Paclitaxel
    Stratum C (AC followed by paclitaxel) Experimental Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. Cyclophosphamide, Doxorubicin Hydrochloride, Paclitaxel

    Eligibility Criteria

    Inclusion Criteria:

    - Patients must have histologically confirmed adenocarcinoma of the breast associated
    with the following clinical stage: IIA, IIB, IIIA, IIIB, or IIIC; patients with stage
    IV disease are also eligible if there is an intention to perform breast surgery after
    neoadjuvant therapy is completed, or in patients participating in clinical trials
    where surgery after neoadjuvant therapy may be an option (eg. E2108)

    - Estrogen receptor (ER), progesterone receptor (PR), and HER2/neu status documented by
    core needle biopsy of the primary tumor and/or regional lymph node must be known
    prior to beginning systemic therapy

    - Patients must have had a bilateral diagnostic mammogram within 6 months of
    registration, and may also have a targeted sonography of the breast and/or
    ipsilateral axilla and magnetic resonance imaging (MRI) if clinically indicated

    - Patients with clinically suspicious axillary lymph node involvement must have either
    aspiration cytology or biopsy prior to beginning therapy

    - It is strongly encouraged that all patients have metallic clips placed in the tumor
    prior to neoadjuvant therapy in order to facilitate evaluation for microscopic
    disease at the time of surgery; placement of clips is particularly encouraged for
    patients being considered for breast conserving surgery

    - No prior chemotherapy, irradiation, or definitive therapeutic surgery (eg, mastectomy
    or lumpectomy or axillary dissection) for this malignancy; patients who have had a
    prior sentinel lymph node biopsy for this malignancy are eligible

    - Patients who received tamoxifen or another selective estrogen receptor modulator
    (SERM) for prevention or for other indications (e.g., osteoporosis, prior ductal
    carcinoma in situ [DCIS]) are eligible; tamoxifen therapy or other SERMs should be
    discontinued at least 1 week before the patient is enrolled on this study

    - The patient is medically suitable candidate for preoperative chemotherapy and surgery
    in the judgment of the treating physicians

    - Ability to understand and the willingness to sign a written informed consent
    document, and willing to provide blood samples before and during preoperative
    therapy; patients are also asked but not required to have research biopsies performed
    before and after therapy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Changes in senescence and secondary biomarkers, including TMEM, mena, and 67LR

    Secondary Outcome Measures

    Changes in quantitative biomarker levels in patients with chemotherapy-responsive and -resistant tumors, including senescence, cell death, TMEM, mena, and 67LR

    Trial Keywords