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Trial Summary


Protocol No.J11155
StatusOPEN TO ACCRUAL
Principal InvestigatorZellars, Richard
ScopeNational
PhasePhase I
Age GroupAdult
TitlePre-Operative PARPi and Irradiation (POPI) in Women with an Incomplete Response to Neo-Adjuvant Chemotherapy for Breast Cancer
DescriptionThe investigators' primary aim is to determine the number of participants who can handle the treatment within specific safety parameters, determine the number of participants who can handle safely the maximum tolerated dose (MTD) (within 50-200 mg/BID dose range) when combining Veliparib and radiation, as well as to identify side effects and their intensity at different dosing levels.

The investigators' secondary aim is to determine the number of participants with post-operative adverse events associated with POPI as well as the pathologic complete and partial response rate in patients treated with POPI.

The investigators' exploratory aim is to serially assess apoptosis/proliferation biomarkers, and gene and protein expression profiles for correlation with tumor response to POPI. This will be primarily evaluated in the expansion cohort.

Study Plan:

It will be a standard 3+3 dose finding trial in which the MTD will be defined as the dose below the level at which >1 DLT is observed in 3-6 patients. Women with node positive disease prior to NAC and >1.0 cm residual breast disease and/or clinically positive nodal disease after NAC will be offered participation in the research phase of this study.

Women with residual disease >1cm or +LN after NAC (Med Onc's choice) will be offered pre-operative Veliparib and concurrent whole breast and regional nodal irradiation. Four (4) dose levels of Veliparib will be evaluated with concurrent whole breast and regional nodal irradiation (WB/RNI). The starting dose of Veliparib will be 50 mg BID, will increase in 50 mg increments to a maximum of 200 mg BID and be delivered concurrently with 235 cGy QD x 16 to the breast and SCV/Axilla. Once the MTD is determined we will further evaluate safety with an expansion cohort which will bring the total number of patients treated at the MTD to 20.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast with confirmed nodal metastasis. Patients must have an axillary nodal evaluation by FNA , SNB or nodal dissection. Patients with squamous, or metaplastic carcinomas or sarcomas of the breast are NOT eligible.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
    Johns Hopkins University
      Treatment TypeTreatment
      ContactPhone: (317) 278-5632
      Email: iutrials@iu.edu