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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 (3000-01-005)
Protocol Number:
Cesar Santa-Maria
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being done 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 breast cancer patients.
Any woman 18 years or older with a BRCA1 or BRCA2 mutation, HER2-negative, primary operable, non-metastatic invasive carcinoma of the breast who have not had prior anti-cancer therapies for current malignancy may be enrolled into the study.
Breast magnetic resonance imaging (MRI), breast ultrasound, and tumor core biopsy will be performed at the Screening (-28 to -1 Day 1). Patients will receive niraparib (200 mg orally [PO]) treatment daily for 28 days (Cycle 1) and then will undergo breast ultrasound at the end of Cycle 1 on Day 28. If ultrasound shows disease progression defined as an increase in tumor volume by greater than 20%, then the patient will discontinue the study. If breast ultrasound shows complete response, partial response, or stable disease by Investigator assessment, the patient will continue niraparib treatment 200 mg PO for an additional cycle (Cycle 2). Patients may receive up to 6 months of niraparib treatment. A breast MRI, breast ultrasound, and core biopsy (only for patients whose tumor is amenable to biopsy) will be performed at the end of Cycle 2. The investigational team will determine if the patient will proceed to surgery or to neoadjuvant chemotherapy.
Last Update
03/05/2019 05:03 AM