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PT-304: Prediction of Response to Neoadjuvant Chemotherapy in Women with Operable Breast Cancer

Principal Investigator: Susan K. Boolbol, MD
Time frame of study: Ongoing
Location of Study:

Mount Sinai Beth Israel
St.Luke's-Mount Sinai West


Continuum Cancer Research Program
(212) 844-6286


The objective of this study is to develop a biomarker (a substance that is injected which allows doctors to determine function of a certain organ or site) to predict response in women treated with neoadjuvant chemotherapy (chemotherapy that is given before main treatment) for breast cancer.  All subjects will receive neoadjuvant chemotherapy with one of two standard of care regimens that must consist of the following agents:  doxorubicin, cyclophosphamide, and a taxane (such as docetaxel or paclitaxel); or, docetaxel and cyclophosphamide.  Upon completion of chemotherapy treatment, subjects will undergo surgical procedures (such as lumpectomy or modified radical mastectomy) determined by the investigator and at that time will be evaluated for response.

Eligibility and Treatment Plan:

  • Subject diagnosed with breast cancer
  • The tumor must be confined to either the breast or to the breast and axilla
  • The subject must be 18 years or older
  • The subject must receive standard of care chemotherapy regimens consisting of either doxorubicin, cyclophosphamide, and a taxane, paclitaxel, or nab-paclitaxel or docetaxel plus cyclophosphamide.

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