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PARP Inhibitor
Niraparib + Trastuzumab for Breast Cancer
Phase 1 & 2
Recruiting
Led By Erica Stringer-Reasor, M.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is able to take oral medication
Patients that have failed at least one anti-HER2 therapy in the metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 100 months
Awards & highlights
Study Summary
This trial will evaluate a new treatment for aggressive, fast-growing HER2-positive breast cancer using a potent PARP inhibitor.
Who is the study for?
This trial is for women over 18 with aggressive HER2+ metastatic breast cancer who've already tried at least one anti-HER2 therapy. They must be able to take pills, have a heart ejection fraction of ≥50%, and not be pregnant or planning pregnancy during the study. Participants need normal organ/marrow function and measurable disease per RECIST v1.1.Check my eligibility
What is being tested?
The trial tests Niraparib combined with Trastuzumab in patients with metastatic HER2+ breast cancer to check safety and effectiveness. The goal is to see if this drug combo can improve survival rates while keeping side effects low compared to current treatments.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to those from compounds like herceptin, issues from prior therapies that haven't healed, or complications related to heart function due to past treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take medicine by mouth.
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I have tried at least one HER2-targeted therapy for my advanced cancer without success.
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My organ and bone marrow functions are normal.
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I am using reliable birth control methods if I can become pregnant.
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I am mostly self-sufficient and can carry out daily activities.
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My breast cancer is HER2 positive, confirmed by a lab test.
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I am a woman aged 18 or older.
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My breast cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Dose-limiting toxicity (DLT)
Phase 2: Objective Response Rate
Secondary outcome measures
Number of adverse events
Phase 1: Niraparib levels
Progression-free survival
Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Anxiety
9%
Back pain
9%
Alanine aminotransferase increased
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Skin tear
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Bruising
4%
Leukocytosis
4%
Unknown infection
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Diarrhea
4%
Esophageal ulcer
4%
Head injury
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Flu like symptoms
4%
Bloating
4%
Hot flashes
4%
Tremor
4%
Hematuria
4%
Hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2: Niraparib 200 mg or 100 mg + Trastuzumab 6 mg/kgExperimental Treatment2 Interventions
The dosage of Niraparib in phase 2 will be determined by the response of patients in Phase 1. A dosage of Niraparib 200 mg will be given along with Trastuzumab 6 mg/kg IV unless a dose limiting toxicity occurs in Phase 1. If so, Niraparib 100 mg will be given with Trastuzumab 6 mg/kg (instead of Niraparib 200 mg).
Group II: Phase 1: Niraparib 200 mg + Trastuzumab 6 mg/kgExperimental Treatment2 Interventions
In phase 1 patients in this first arm will receive 200 mg Niraparib in combination with 6 mg/kg Trastuzumab given IV every 3 weeks.
Group III: Phase 1: Niraparib 100 mg + Trastuzumab 6 mg/kgExperimental Treatment2 Interventions
In phase 1 patients in this second arm will receive Niraparib 100 mg in combination with 6 mg/kg Trastuzumab given IV every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
VFoundationUNKNOWN
Breast Cancer Research Foundation of AlabamaUNKNOWN
1 Previous Clinical Trials
23 Total Patients Enrolled
Susan G. Komen Breast Cancer FoundationOTHER
66 Previous Clinical Trials
220,171 Total Patients Enrolled
41 Trials studying Breast Cancer
215,072 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a high dose of doxorubicin or a similar drug.You have been diagnosed with HIV.I have recovered from serious side effects of my previous treatments.It has been at least two weeks since my last radiation therapy.I am not on long-term steroids or other drugs that weaken my immune system.I can take medicine by mouth.You have had moderate or severe allergic reactions to similar medicines as niraparib.You have had serious allergic reactions to drugs similar to herceptin.I have had cancer other than breast cancer in the last 5 years.I have a serious health condition that is not well-controlled.I have tried at least one HER2-targeted therapy for my advanced cancer without success.My organ and bone marrow functions are normal.Your heart's pumping function, measured by a special test, is normal.I am using reliable birth control methods if I can become pregnant.I have metastatic breast cancer, am HER2 positive, and haven't worsened after at least one HER2 therapy.I have cancer that has spread to my brain or spinal cord.I have a known BRCA 1 or BRCA 2 gene mutation.I am not currently receiving any cancer treatments.I have been treated with a PARP inhibitor before.I have not taken any hormonal therapy for at least a week.I am mostly self-sufficient and can carry out daily activities.My breast cancer is HER2 positive, confirmed by a lab test.I need oxygen therapy.My cancer can be either hormone-receptor positive or negative.I am a woman aged 18 or older.I have active hepatitis B or C.My breast cancer has spread to other parts of my body.You must have a specific amount of disease that can be measured using a standard method.I do not have heart or lung problems.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Niraparib 100 mg + Trastuzumab 6 mg/kg
- Group 2: Phase 1: Niraparib 200 mg + Trastuzumab 6 mg/kg
- Group 3: Phase 2: Niraparib 200 mg or 100 mg + Trastuzumab 6 mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to take part in this clinical investigation?
"As per information on clinicaltrials.gov, the trial is currently attempting to secure participants. The study was initially published on September 6th 2019 and underwent its last revision on November 9th 2022."
Answered by AI
To what maladies does Niraparib provide therapeutic relief?
"Niraparib is the go-to medication for treating breast cancer. Additionally, it can be used as a preventative measure against recurrence of high risk cases, primary peritoneal cancer, and other initial treatments."
Answered by AI
What is the upper limit for individuals participating in this experiment?
"To fulfil the requirements of this experimental trial, 40 applicants with suitable eligibility criteria are necessary. Those interested may register for the study at either University of Chicago in Illinois or University of Pennsylvania in Philadelphia."
Answered by AI
What is the current geographic breadth of this investigation?
"The trial is taking place in multiple locations throughout the nation, including but not limited to: University of Chicago (Chicago), University of Pennsylvania (Philadelphia), and Mayo Clinic (Rochester). Altogether there are 7 different sites available."
Answered by AI
Have there been prior assessments of Niraparib's efficacy?
"Ospedale di Circolo e Fondazione Macchi was the first research centre to investigate niraparib in 1999. Since then, 370 experiments have been completed and presently 288 live clinical trials are underway, with a heavy concentration located in Chicago."
Answered by AI
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