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A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy.

Study Summary

  • This study is looking at triple negative breast cancer patients that have followed a specific course of treatment
    • Patients must complete neoadjuvant chemotherapy and resection of the primary tumor
    • They would then be eligible if they have residual cancer in the breast
  • Once patients are determined to be eligible, they will be randomized (like flipping a coin) to either receive either:
    • Cisplatin or Carboplatin, which is chemotherapy given via infusion once every three weeks
    • Capecitabine, which is a taken orally twice a day

Protocol

  • EA1131

Phase

  • III

Investigator

  • Dr. Kenneth Blankstein

Disease

  • Triple Negative Breast Cancer

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Inclusion

  • Histologically confirmed triple negative invasive breast cancer
  • Must have completed neoadjuvant chemotherapy with taxane with or without anthracycline
  • Must have had completed definitive resection of primary tumor
    • Must have had residual invasive cancer at time of surgery
  • Post-mastectomy radiotherapy is required for certain patients per protocol
  • Cannot be Stage IV/metastatic

 

Exclusion

  • Cannot have had cisplatin, carboplatin or capecitabine
  • Cannot have significant infection or active neuropathy

 


If you have any questions regarding this study or think that
you or your loved one may be eligible, please feel free to contact:

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