Clinical Trials /

Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment

NCT03329937

Description:

This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in patients with HER2 negative and BRCAmut localized breast cancer (primary tumor ≥1 cm).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: 3000-01-005
  • NCT ID: NCT03329937

Conditions

  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation

Interventions

DrugSynonymsArms
NiraparibZejulaSafety and Antitumor Evaluation

Purpose

This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in patients with HER2 negative and BRCAmut localized breast cancer (primary tumor >1 cm).

Trial Arms

NameTypeDescriptionInterventions
Safety and Antitumor EvaluationExperimentalTo evaluate the antitumor activity and safety of Niraparib therapy.
  • Niraparib

Eligibility Criteria

        Inclusion Criteria:

          -  Females age ≥ 18 years old

          -  Patients with a 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

          -  ECOG performance status of 0 or 1

          -  Adequate organ function, defined as follows:

          -  Patient must have recovered to Grade 1 toxicity from prior cancer therapy

          -  Able to take oral medications

          -  Patient (of childbearing potential) 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.

          -  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 (ie, Hepatitis B or C)

          -  Prior treatment with a known PARP inhibitor

          -  Other active malignancy that warrants systemic therapy

          -  Known history of MDS or AML
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Preliminary antitumor activity of niraparib assessed as the tumor response rate based on the change in tumor volume as measured by breast MRI
Time Frame:Approximately 2-Years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Preliminary antitumor activity of niraparib assessed by presence of pCR
Time Frame:Approximately 2-Years
Safety Issue:
Description:
Measure:Preliminary antitumor activity of niraparib assessed by percentage change in tumor volume from baseline after 2 months of niraparib treatment
Time Frame:Approximately 2- Months
Safety Issue:
Description:
Measure:Preliminary antitumor activity of niraparib assessed by tumor response rate based on the change in tumor volume as measured by breast ultrasound
Time Frame:Approximately 2-Years
Safety Issue:
Description:
Measure:Evaluate safety and tolerability of niraparib using Common Terminology Criteria for Adverse Events (CTCAE v.4.03)
Time Frame:Approximately 2-Years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tesaro, Inc.

Last Updated

March 29, 2018