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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
Must not have
Prior treatment of a total doxorubicin >360 mg/m2 (or equivalent)
Patients who have not recovered from CTCAE, v. 4.03 grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment
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
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a high dose of doxorubicin or a similar drug.
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I have recovered from serious side effects of my previous treatments.
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I am not on long-term steroids or other drugs that weaken my immune system.
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I have had cancer other than breast cancer in the last 5 years.
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I have metastatic breast cancer, am HER2 positive, and haven't worsened after at least one HER2 therapy.
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I have cancer that has spread to my brain or spinal cord.
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I have a known BRCA 1 or BRCA 2 gene mutation.
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I am not currently receiving any cancer treatments.
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I have been treated with a PARP inhibitor before.
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I need oxygen therapy.
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I have active hepatitis B or C.
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I do not have heart or lung problems.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Dose-limiting toxicity (DLT)
Phase 2: Objective Response Rate
Secondary study objectives
Number of adverse events
Phase 1: Niraparib levels
Progression-free survival

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
22%
Dyspnea
17%
Platelet count decreased
17%
Headache
17%
Mucositis oral
17%
Creatinine increased
13%
Rash maculo-papular
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Dehydration
9%
Cough
9%
Urinary tract infection
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Upper respiratory infection
4%
Hoarseness
4%
Hypotension
4%
Postnasal drip
4%
Head injury
4%
Hyponatremia
4%
Flu like symptoms
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Hot flashes
4%
Hypokalemia
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Edema limbs
4%
Bruising
4%
Esophageal ulcer
4%
Hyperkalemia
4%
Peripheral sensory neuropathy
4%
Leukocytosis
4%
White blood cell decreased
4%
Skin tear
4%
Oral petechia
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2400

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
67 Previous Clinical Trials
220,318 Total Patients Enrolled
41 Trials studying Breast Cancer
215,075 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
25 Previous Clinical Trials
2,935 Total Patients Enrolled
15 Trials studying Breast Cancer
1,993 Patients Enrolled for Breast Cancer
University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,444,110 Total Patients Enrolled
32 Trials studying Breast Cancer
4,319 Patients Enrolled for Breast Cancer
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,516 Total Patients Enrolled
3 Trials studying Breast Cancer
131 Patients Enrolled for Breast Cancer
Erica Stringer-Reasor, M.D.Principal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Breast Cancer
15 Patients Enrolled for Breast Cancer

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03368729 — Phase 1 & 2
Breast Cancer Research Study Groups: Phase 1: Niraparib 100 mg + Trastuzumab 6 mg/kg, Phase 1: Niraparib 200 mg + Trastuzumab 6 mg/kg, Phase 2: Niraparib 200 mg or 100 mg + Trastuzumab 6 mg/kg
Breast Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03368729 — Phase 1 & 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03368729 — Phase 1 & 2
~6 spots leftby Dec 2025
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