Research & Clinical Trials

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NCT01618357

Pre-Operative PARPi and Irradiation (POPI) in Women With an Incomplete Response to Neo-Adjuvant Chemotherapy for Breast Cancer

Study identifier: NCT01618357
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Veliparib (Abbvie)

Eligibility:

  • Patient must be 18 years of age or older
  • Patients must have an axillary nodal evaluation either by FNA or SNB in accordance with their institutional guidelines.
  • Patient must have a Medical Oncology consult and be recommended to receive neoadjuvant chemotherapy for a stage II through IV carcinoma.

Type of study:

Phase I

Treatment:
All subjects will receive preoperative Neo-Adjuvant Chemotherapy (NAC)treatment but only those with an incomplete response to NAC will be treated with the Preoperative experimental portion of the trial explained below.

  • Patients who have a complete response after the administration of preoperative Neo-Adjuvant Chemotherapy (NAC) (per the recommendation by the treating medical oncologist) will go to the control arm of this trial. That control arm will include surgery followed by more Neo-Adjuvant (NAC) treatment if residual disease is still present.
  • Those with residual disease after surgery will receive radiation with Veliparib.

Study site:

Maryland
Baltimore
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact: Richard Zellars, M.D. 410-502-1421 zellari@jhmi.edu
Contact: Shirley DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu


Page updated 06/10/13