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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 to 75OtherLJCC 07-03

Trial 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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Leo W. Jenkins Cancer Center at ECU Medical School

    Paul Walker, MD, Principal Investigator
    Paul Walker, MD
    Ph: 252-744-1888

    Link to the current record.
    NLM Identifier NCT00542191 processed this data on May 27, 2015

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to