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Clinical Trial 19394

Cancer Type: Breast
Interventions:Niraparib

Study Type: Treatment
Phase of Study: Early Phase I
Investigators:

  • Heather Han

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

An Open-Label, Single-Arm Pilot Study Evaluating The Antitumor Activity And Safety Of Niraparib As Neoadjuvant Treatment In Localized, Her2-Negative, Brca-Mutant Breast Cancer Patients

Summary

The purpose of this research study is to: · Test how safe Niraparib (Study Drug) is and how well it works.

Objective

Primary: To evaluate the preliminary antitumor activity of niraparib assessed as the tumor response rate based on the change in tumor volume as measured by breast MRI, observed after treatment with niraparib in the neoadjuvant treatment of localized, human epidermal growth factor receptor 2 (HER2)-negative, breast cancer susceptibility gene (BRCA) mutant (BRCAmut) breast cancer patients.

Inclusion Criteria

  • Age ≥ 18 years old.
  • Deleterious or suspected deleterious BRCA1 or BRCA2 mutation (germline or somatic).
  • Histologically confirmed HER2-negative localized breast cancer by core biopsy.
  • Primary operable, non-metastatic invasive carcinoma of the breast, confirmed histologically by core biopsy.
  • Primary tumor size >/= 1 cm.
  • Measurable disease by breast ultrasound and MRI.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.
  • Patient must have recovered to Grade 1 toxicity from prior cancer therapy.
  • Able to take oral medications.
  • Female participant is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from Screening through 180 days after the last dose of study drug, or is of nonchildbearing potential. Male participant agrees to use an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Able to understand the study procedures and agree to participate in the study by providing written informed consent.

  • Exclusion Criteria

  • Prior anti-cancer therapies for current malignancy.
  • Known evidence of distant metastasis.
  • Known hypersensitivity to the components of niraparib components or their formulation excipients.
  • Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
  • Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study drug, or is not in the best interest of the patient to participate.
  • Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study drug or within the 180 day period after the last dose of study drug.
  • Immunocompromised patients.
  • Known active hepatic disease (i.e., Hepatitis B or C).
  • Prior treatment with a known PARP inhibitor.
  • Other active malignancy that warrants systemic therapy.
  • Known history of MDS or AML.