Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Niraparib — DRUG
  Niraparib is a potent, orally active, highly selective poly adenosine diphosphate (\[ADP\]-ribose) polymerase 1 (PARP1) and PARP2 inhibitor. It will be supplied as 100 mg capsules and will be administered at starting dose of 200 mg PO daily throughout 28 days for 2 cycles (each cycle is 28 days), with the potential for an additional 4 cycles (maximum total of 6 cycles) at the assigned dose and schedule.

Study Details

This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor 2 (HER2)-negative and breast cancer susceptibility gene mutant (BRCAmut) localized breast cancer (primary tumor \>=1 centimeters \[cm\]). Breast magnetic resonance imaging (MRI), breast ultrasound, and tumor core biopsy will be performed at the screening (Days -28 to -1). Participants will receive niraparib (200 milligrams \[mg\] orally \[PO\]) treatment daily for 28 days (Cycle 1) and then will undergo breast ultrasound at the end of Cycle 1 on Day 28. Based on breast ultrasound reports, the participants will either discontinue the study (disease progression) or will continue niraparib treatment (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) for an additional cycle (Cycle 2). A breast MRI and breast ultrasound will be performed at the end of Cycle 2. Approximately 21 participants will be enrolled in this study and the study duration will be approximately 2 years.

Key Dates

Start date

Apr 12, 2018

Status verified

Dec 2024

Primary completion

Jan 2, 2020

Completion

Mar 31, 2020

Study Design

Enrollment

21 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Participants with HER2-negative and BRCAmut breast cancer
  Participants with HER2-negative and BRCAmut localized breast cancer (primary tumor \>=1 cm) will receive niraparib (200 mg PO).

Primary Outcome Measure

Percentage of Participants With Tumor Response Measured by Breast MRI [ Time Frame: At 2 months ]