Clinical Trials /

Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer

NCT01855828

Description:

The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin) concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The study will also test the safety of this therapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Phase 2 Trial of <span class="go-doc-concept go-doc-intervention">Pertuzumab and Trastuzumab</span> With Weekly <span class="go-doc-concept go-doc-intervention">Paclitaxel</span> and <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> for <span class="go-doc-concept go-doc-biomarker">HER2</span> Positive <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
  • Official Title: Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT01855828

    ORG ID: 1305012136

    Trial Conditions

    Her2-Positive Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Pertuzumab Perjeta Chemo plus Pertuzumab,Trastuzumab
    Trastuzumab Herceptin Chemo plus Pertuzumab,Trastuzumab
    Paclitaxel Taxol Chemo plus Pertuzumab,Trastuzumab
    5-fluorouracil 5-FU Chemo plus Pertuzumab,Trastuzumab
    Epirubicin Ellence Chemo plus Pertuzumab,Trastuzumab
    Cyclophosphamide Cytoxan Chemo plus Pertuzumab,Trastuzumab

    Trial Purpose

    The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the
    anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin)
    concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The
    study will also test the safety of this therapy.

    Detailed Description

    Subjects will receive 6 months of T-FEC chemotherapy concomitant with trastuzumab and
    pertuzumab before surgery. Subsequently, subjects will undergo surgery to remove any cancer
    from the breast and axillary lymph nodes that may have survived the chemotherapy. It is
    expected that the majority of women will have no viable cancer left in the breast or lymph
    nodes by the time all chemotherapy is completed.

    Trial Arms

    Name Type Description Interventions
    Chemo plus Pertuzumab,Trastuzumab Experimental During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC). Pertuzumab, Trastuzumab, Paclitaxel, 5-fluorouracil, Epirubicin, Cyclophosphamide

    Eligibility Criteria

    Inclusion Criteria:

    - Patients with histologically confirmed stage I-III, HER2-positive invasive breast cancer
    for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment
    following NCCN practice guidelines.

    HER2 overexpression or amplification will be based on local test results and is defined as
    either:

    (i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to
    10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of
    more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to
    chromosome 17 signals) of greater than or equal to 2.0.

    - Patients with synchronous bilateral breast cancers are eligible if at least one of
    the tumors is HER2-positive.

    - Left Ventricular Ejection Fraction (LVEF) greater or equal to 50% at baseline as
    determined by either ECHO or MUGA, or within the institution's normal limits.

    - Women of childbearing potential must have a negative pregnancy test (serum or urine
    beta HCG) prior to initiation of chemotherapy. Both female and male breast cancer
    patients who are sexually active have to agree to practice contraception while
    participating in the trial and for 3 month after completion of therapy.

    - Adequate bone marrow function as indicated by the following:

    - ANC greater than or equal to 1500/uL

    - Platelets greater than or equal to 100,000/uL

    - Hemoglobin greater than or equal to 10 g/dL

    - Adequate renal function, as indicated by creatinine less than or equal to 1.5 times
    upper limit of normal (ULN)

    - Adequate liver function, as indicated by bilirubin less than or equal to 1.5 X ULN
    and AST or ALT less than or equal to 2x ULN.

    - Signed informed consent.

    Exclusion Criteria:

    Patients will be excluded from the study based on any of the following criteria:

    - Patients who underwent partial excisional biopsy, lumpectomy, segmental mastectomy,
    modified radical mastectomy or sentinel node biopsy and, therefore cannot be assessed
    for pathologic response accurately.

    - Patients who are high risk for developing the following anthracycline, paclitaxel,
    trastuzumab or pertuzumab related toxicities including:

    History of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled
    hypertension despite adequate medications Pre-existing peripheral neuropathy > grade 3
    Prior anthracycline therapy Known hypersensitivity to any of the study medications
    Patients older than age 65 due to increased risk of cardiotoxicity

    - Active infection requiring systemic antibiotic therapy.

    - Pregnant or lactating women

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 65 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Pathologic Complete Response

    Secondary Outcome Measures

    Safety

    Clinical Response

    Residual Cancer burden score

    Trial Keywords