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

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