Study Details

Open

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

The purpose of this study is to evaluate a new treatment routine for patients with metastatic HER2 -positive breast cancer. We want to find out what effects, good and bad, using a Poly (ADP-Ribose) polymerase (PARP) inhibitor called niraparib in combination with trastuzumab has on patients with metastatic HER2- positive breast cancer.

Age & Gender

18 years ~ 99 years
Female

Location

North Carolina (Statewide)

What will be asked of you

This study involves blood draws, physical exams, echocardiograms, CT scans, research biopsies, and receipt of study drugs. You will meet with a member of the study team in addition to your oncology care team during your visits.

Total length of participation:
Treatment may continue until one of the following criteria applies: • Your disease progresses • You get an illness that prevents continuing treatment • You

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate:

You have been diagnosed with with HER2 positive metastatic breast cancer
You must have received at least one type of therapy for your HER2 positive metastatic breast cancer and your cancer has progressed
You have been diagnosed with either Estrogen/progesterone receptor positive OR negative breast cancer
You are able to swallow pills
You are not pregnant or breastfeeding

Not eligible if:

You have active central nervous system/brain metastases from your breast cancer
You have been told that you have a BRCA1 or BRCA2 mutation
You have had radiation therapy for your breast cancer within 2 weeks of entering the study or have received hormonal therapy for your breast cancer
You have received another investigational medication within 4 weeks of entering the study.
You have had major surgery within 3 weeks of starting the study medications.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Cherokee Indian Hospital
1 Hospital Rd, Cherokee, NC 28719, USA

Additional Study Information

Principal Investigator

Claire Dees
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

20-0527

ClinicalTrials.gov

NCT03368729