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Niraparib for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
GSK Investigational Site, Skokie, ILBreast CancerNiraparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the effectiveness of Niraparib in treating breast cancer in participants with either a BRCA gene mutation or BRCA wild type. Participants who have completed cancer treatment in the past are eligible for this trial.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Niraparib
1
Niraparib
1
Niraparib

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 8 years

Year 8
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (Scores on a scale)
Change from Baseline in the Functional Assessment of Cancer Therapy - General Population(FACT-GP5) (Scores on a scale)
Patient reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (Scores on a scale)
Up to 4 years
Disease-free survival (DFS)
Distant recurrence-free survival (DRFS)
Up to 8 years
Number of participants with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), TEAEs leading to death, and AEs leading to discontinuation
Number of participants with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), adverse events of special interest (AESIs), TEAEs leading to death, TEAEs leading to dose modifications and discontinuation
Pharmaceutical Preparations
Number of participants with clinically significant changes in laboratory parameters, vital signs, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications
Overall survival (OS)
Time to progression on next anticancer therapy (TTP)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Niraparib
1
Niraparib
1
Niraparib

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Constipation
48%Anaemia
43%Fatigue
38%Dyspnoea
24%Platelet count decreased
24%Vomiting
24%Stomatitis
24%Oedema peripheral
19%Blood alkaline phosphatase increased
19%Insomnia
19%Arthralgia
19%Pruritus
14%Chills
14%Diarrhoea
14%Dysgeusia
14%Weight decreased
14%Cough
14%Pneumonia
14%Pain
14%Upper respiratory tract infection
14%Neutrophil count decreased
14%Back pain
14%Muscular weakness
10%Non-cardiac chest pain
10%Chest pain
10%Gait disturbance
10%Wheezing
10%Productive cough
10%Urinary tract infection
10%Haemorrhoids
10%Alanine aminotransferase increased
10%Proctalgia
10%Pleural effusion
10%Atrial fibrillation
10%Haemorrhoidal haemorrhage
10%Oropharyngeal pain
10%Dehydration
10%Hypokalaemia
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Blood creatinine increased
10%Lymphocyte count decreased
10%Neuropathy peripheral
10%Anxiety
10%Depression
10%Rash maculo-papular
10%Erythema
10%Pain of skin
10%Overdose
10%Hypothyroidism
10%Vision blurred
5%Diverticulitis
5%Angina pectoris
5%Neuroendocrine carcinoma of the skin
5%Candida infection
5%Dizziness
5%Fall
5%Haematochezia
5%Tachycardia
5%Contusion
5%Cancer pain
5%Hyponatraemia
5%Dysphonia
5%Toxicity to various agents
5%Gastrooesophageal reflux disease
5%Peripheral sensory neuropathy
5%Pulmonary embolism
5%Sepsis
5%Hepatic enzyme increased
5%Lipase increased
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Abdominal pain
5%Nasal congestion
5%Pyrexia
5%Asthenia
5%Malaise
5%Hypomagnesaemia
5%Amylase increased
5%Headache
5%Lethargy
5%Pain in extremity
5%Hyperhidrosis
5%Sinus tachycardia
5%Hypotension
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Constipation with 48%, Anaemia with 48%, Fatigue with 43%.

Trial Design

3 Treatment Groups

Cohort1 Participants with tBRCAmut HER2-breast cancer(Independent of HR status,i...
1 of 3
Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,i...
1 of 3
Cohort 2: Participants with tBRCAwt TNBC
1 of 3

Experimental Treatment

800 Total Participants · 3 Treatment Groups

Primary Treatment: Niraparib · Has Placebo Group · Phase 3

Cohort1 Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)Experimental Group · 2 Interventions: Placebo, Niraparib · Intervention Types: Drug, Drug
Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)Experimental Group · 2 Interventions: Placebo, Niraparib · Intervention Types: Drug, Drug
Cohort 2: Participants with tBRCAwt TNBCExperimental Group · 2 Interventions: Placebo, Niraparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640
Niraparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 years

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,661 Previous Clinical Trials
7,949,555 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,144 Patients Enrolled for Breast Cancer
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,568 Previous Clinical Trials
6,133,521 Total Patients Enrolled
2 Trials studying Breast Cancer
2,323,730 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
You are eligible if you have HR+ breast cancer and are on a stable regimen of endocrine therapy.
A tumor tissue specimen of the primary tumor is required for testing.

Who else is applying?

What state do they live in?
California50.0%
North Carolina25.0%
Virginia25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
References

Frequently Asked Questions

Is this research project open to new participants?

"Yes. The clinical trial is enrolling 800 participants between 27 locations, as stated on clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

What are the long-term risks of taking Niraparib?

"Niraparib is considered safe based on its Phase 3 status, as well as the efficacy data and multiple rounds of safety testing." - Anonymous Online Contributor

Unverified Answer

What other opportunities for research exist with Niraparib?

"Currently, there are 97 Niraparib trials underway with 13 of them in Phase 3. The majority of these Washington, D.C., however 2639 locations worldwide are running these studies." - Anonymous Online Contributor

Unverified Answer

What other similar studies have been conducted in the past?

"Research into niraparib began in 2016 with a clinical trial that was sponsored by Myriad Genetics, Inc. After the Phase 3 drug approval in 2016, 97 live trials for Niraparib are ongoing in 478 cities and 49 countries." - Anonymous Online Contributor

Unverified Answer

How large is the study group for this research?

"Yes, you are correct. The information available on clinicaltrials.gov affirms that this study is currently looking for participants. The trial was originally posted on June 28th, 2021 and the most recent update was on September 29th, 2022. They are hoping to enroll 800 individuals total at 27 sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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