Clinical Trials /

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

NCT00542191

Description:

This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Phase II Trial of Neoadjuvant Metronomic <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> in Triple-Negative <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
  • Official Title: Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT00542191

    ORG ID: LJCC 07-03

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin Single arm study; taxol, XRT, gemzar and carbo

    Trial Purpose

    This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone
    will gather a foundation of primary tumor and axillary lymph nodal response to primary
    chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome
    data. This comparative data can then be used in building subsequent trials.

    Detailed Description

    Women with a diagnosed "triple-negative" proxy of basal-like breast cancer confirmed on a
    core biopsy and larger than 2 cm will be treated neoadjuvantly with the Livingston
    metronomic regimen of 12 weeks of weekly doxorubicin 24 mg/m2 and daily oral
    cyclophosphamide 60 mg/m2 followed by 12 successive weeks of taxol 80 mg/m2 and carboplatin
    AUC 2. Although clinical response will be evaluated prior to surgery, the primary end-point
    is the pathologic response. Secondary end-points will be DFS and OS based upon standard of
    care surveillance. A pathologic complete response (pCR) will require no histologic evidence
    of residual malignant cells seen in the primary tumor area specimen or the lymph nodes.
    Standard of care surgery and radiation therapy will be undertaken.

    Trial Arms

    Name Type Description Interventions
    Single arm study; taxol, XRT, gemzar and carbo Other Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative
    invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH
    preferred; HER2 0 or 1+ by IHC acceptable)

    - Primary tumor size 2cm or greater by physical exam or radiographic
    measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.)

    - Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable
    or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam
    acceptable.)

    - Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3

    - Normal myocardial left ventricular function

    - Serum creatinine < 2.0 mg/dl

    - Total bilirubin and AST < 3X upper limits normal

    Exclusion Criteria:

    - Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a
    second breast primary, patient eligible for this protocol)

    - Another active cancer present

    - Medical contraindications to chemotherapy or surgery

    - First trimester pregnancy

    - Breast feeding

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 75 Years

    Eligible Gender: Female

    Primary Outcome Measures

    1) Pathologic response

    Secondary Outcome Measures

    1) Clinical response 2) Disease free survival (DFS) 3) Overall Survival (OS)

    Trial Keywords

    Triple negative (ER/PR negative; HER2 negative)