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PARP Inhibitor

Niraparib + Radiotherapy for Triple Negative Breast Cancer (UNITY Trial)

Phase 1
Waitlist Available
Led By Alice Ho, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Residual invasive disease after NAC (any size), or at least 1.0 cm in patients who do not receive NAC and undergo surgery first
Ability to swallow (whole) and retain oral medications
Must not have
Prior malignancy within 5 years of study enrollment
Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing Niraparib as a possible treatment for triple negative breast cancer.

Who is the study for?
This trial is for adults with non-metastatic triple negative breast cancer who've had surgery and are planning postoperative radiation therapy. They must have some remaining invasive disease, not be pregnant or breastfeeding, agree to contraception use, and have good organ function. Exclusions include prior PARP inhibitor treatment, certain small tumors, significant other diseases or unresolved toxicities from past treatments.
What is being tested?
The study tests Niraparib given alongside standard postoperative radiation therapy in patients with triple negative breast cancer. It aims to see if this combination can improve outcomes compared to radiation alone.
What are the potential side effects?
Niraparib may cause blood disorders like anemia or low platelets, fatigue, nausea, digestive issues, and could affect fertility. Radiation therapy might lead to skin changes at the treated site, tiredness and swelling of the breast area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I still have cancer after chemotherapy, or my tumor is at least 1.0 cm without chemotherapy.
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I can swallow and keep down pills.
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My breast cancer is triple-negative and has not spread to other parts of my body.
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I had surgery to remove my breast cancer and check the lymph nodes.
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I agree to use birth control from the start of the study until 90 days after it ends.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had any other cancer in the last 5 years.
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I have a history of MDS or AML.
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I have not had cancer treatments for at least 2 weeks and any side effects have gone.
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I have scleroderma or systemic lupus erythematosus.
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I have no lasting side effects from previous treatments.
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I have never had radiation therapy on the same side breast or nearby lymph nodes.
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I have a known p53 gene mutation.
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I weigh less than 77kg or my platelet count is below 150,000.
Select...
My breast cancer is small, has not spread to lymph nodes, and is triple negative. I had surgery after chemotherapy.
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I have severe anemia, low white blood cell count, or low platelet count from my last chemo.
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I have never taken PARP inhibitors before.
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I had major surgery less than 3 weeks ago but have recovered from it.
Select...
I have brain or spinal cord cancer spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose
Secondary study objectives
Breast cosmesis
Distant Relapse
Locoregional Relapse
+1 more

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
9%
Urinary tract infection
9%
Cough
9%
Dehydration
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Postnasal drip
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Peripheral sensory neuropathy
4%
Hyperkalemia
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Upper respiratory infection
4%
Leukocytosis
4%
White blood cell decreased
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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment2 Interventions
* Niraparib will be administered orally on a daily basis * Radiation Therapy will be administered concurrently with Niraparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Niraparib
FDA approved

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,535 Total Patients Enrolled
3 Trials studying Breast Cancer
131 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,310 Total Patients Enrolled
80 Trials studying Breast Cancer
131,171 Patients Enrolled for Breast Cancer
Alice Ho, MD3.04 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03945721 — Phase 1
Breast Cancer Research Study Groups: Niraparib
Breast Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03945721 — Phase 1
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03945721 — Phase 1
~0 spots leftby Dec 2024
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