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

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ClinicalTrials.gov Identifier: NCT03329937
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast BRCA1 Gene Mutation BRCA2 Gene Mutation Drug: Niraparib Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Safety and Antitumor Evaluation
To evaluate the antitumor activity and safety of Niraparib therapy.
Drug: Niraparib
Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
Other Name: Zejula




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Preliminary antitumor activity of niraparib assessed by presence of pCR [ Time Frame: Approximately 2-Years ]
  2. 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 ]
  3. 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 ]
  4. Evaluate safety and tolerability of niraparib using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) [ Time Frame: Approximately 2-Years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patient must have recovered to Grade 1 toxicity from prior cancer therapy
  • Able to take oral medications
  • Female 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.
  • Male patient 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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329937


Contacts
Contact: Beth Zharoff Director, Patient Focused Clinical Trial Engagement 781-209-5485 bzaharoff@tesarobio.com

Locations
United States, California
Pacific Shores Medical Oncology Recruiting
Long Beach, California, United States, 90808
United States, Florida
Florida Cancer Specialists- South Recruiting
Fort Myers, Florida, United States, 33901
Memorial Health Care System Recruiting
Pembroke, Florida, United States, 33028
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at John Hopkins Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Oregon
Providence Portland Medical center Recruiting
Portland, Oregon, United States, 97231
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Tesaro, Inc.

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT03329937     History of Changes
Other Study ID Numbers: 3000-01-005
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents