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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 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

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%

Dizziness

22%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Hyperkalemia

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

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