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



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/13/2018
Start Date:April 19, 2018
End Date:March 2020
Contact:Beth Zharoff Director, Patient Focused Clinical Trial Engagement
Email:bzaharoff@tesarobio.com
Phone:781-209-5485

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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

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).


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
We found this trial at
11
sites
Long Beach, California 90808
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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Baltimore, MD
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Fort Myers, Florida 33916
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Fort Myers, FL
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, NY
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Pembroke, Florida 33028
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Pembroke, FL
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Rochester, Minnesota 55905
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Rochester, MN
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Tampa, Florida 33612
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Tampa, FL
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