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PARP Inhibitor
Niraparib + Radiotherapy for Triple Negative Breast Cancer (UNITY Trial)
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
UNITY Trial 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.Check my eligibility
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.See study design
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.
UNITY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I still have cancer after chemotherapy, or my tumor is at least 1.0 cm without chemotherapy.
Select...
I can swallow and keep down pills.
Select...
My breast cancer is triple-negative and has not spread to other parts of my body.
Select...
I had surgery to remove my breast cancer and check the lymph nodes.
Select...
I agree to use birth control from the start of the study until 90 days after it ends.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
UNITY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Breast cosmesis
Distant Relapse
Locoregional Relapse
+1 moreSide 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%
Dyspnea
22%
Abdominal pain
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%
Anxiety
9%
Alanine aminotransferase increased
9%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Unknown infection
4%
Ascites
4%
Bruising
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%
Head injury
4%
Postnasal drip
4%
Hypokalemia
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
UNITY 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
10,536 Total Patients Enrolled
3 Trials studying Breast Cancer
131 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,470 Total Patients Enrolled
81 Trials studying Breast Cancer
132,912 Patients Enrolled for Breast Cancer
Alice Ho, MD3.04 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I still have cancer after chemotherapy, or my tumor is at least 1.0 cm without chemotherapy.I have not had any other cancer in the last 5 years.I have a history of MDS or AML.I am 18 years old or older.I have not had cancer treatments for at least 2 weeks and any side effects have gone.I can swallow and keep down pills.I have scleroderma or systemic lupus erythematosus.I have no lasting side effects from previous treatments.I have never had radiation therapy on the same side breast or nearby lymph nodes.I haven't had a blood transfusion in the last 4 weeks.I have a known p53 gene mutation.You have had allergic reactions to similar drugs or ingredients to niraparib.I weigh less than 77kg or my platelet count is below 150,000.I am not pregnant and agree to avoid pregnancy during the study.I agree not to donate blood during and for 3 months after the study.I weigh at least 77kg and my platelet count is over 150,000.I have been on a stable dose of corticosteroids for at least 4 weeks.My breast cancer is small, has not spread to lymph nodes, and is triple negative. I had surgery after chemotherapy.I have severe anemia, low white blood cell count, or low platelet count from my last chemo.My breast cancer is triple-negative and has not spread to other parts of my body.I am willing to stop any cancer treatments like chemotherapy or immunotherapy 2 weeks before starting radiation therapy.I had surgery to remove my breast cancer and check the lymph nodes.I have never taken PARP inhibitors before.I have tumor left after surgery that wasn't removed, except at the chest wall or skin.I do not have any major health issues that could worsen due to the study.I had major surgery less than 3 weeks ago but have recovered from it.I am planning to receive radiation therapy to my breast or chest area after surgery.I have brain or spinal cord cancer spread.I haven't taken any colony-stimulating factors in the last 4 weeks.My organs are functioning well, as tested within the last 30 days.I agree to use birth control from the start of the study until 90 days after it ends.I am fully active and can carry on all my pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib
Awards:
This trial has 2 awards, including:- 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.
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.
How many participants have signed up for this medicinal trial?
"Affirmative. The clinicaltrials.gov website attests that this medical study, which was first made available on July 11th 2019, is actively recruiting subjects. A total of 20 participants must be enlisted from 2 different research centres."
Answered by AI
Are there other precedents of Niraparib in clinical experimentation?
"Currently, there are 99 live trials investigating the effects of Niraparib. Of those studies, 13 have reached Phase 3. Despite being based in Washington D.C., clinical sites across 2817 different locations are researching this treatment option."
Answered by AI
Are there any vacant spots in this research program for potential participants?
"Affirmative, clinicaltrials.gov data affirms that this research endeavour is actively looking for participants, having been initially posted on July 11th 2019 and recently updated October 27 2021. Two sites are currently recruiting 20 people in total."
Answered by AI
Is this trial a pioneering attempt for its type?
"Research into niraparib began in 2016 with the first trial sponsored by Myriad Genetics, Inc. After successful completion of this initial study on 733 participants, Niraparib gained phase 3 drug approval. At present time there are 99 active trials for it across 49 countries and 485 cities around the world."
Answered by AI
Has the United States Food and Drug Administration sanctioned Niraparib?
"Due to the Phase 1 status, Niraparib is estimated to have a relative safety score of 1. This reflects the limited clinical data available for this medication regarding both efficacy and safety."
Answered by AI
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