Neratinib Arm for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University Health Network: Princess Margaret Cancer Centre, Toronto, Canada
Breast Cancer+2 More
Neratinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 2 study for patients with resected Stage I-III HER2+ breast cancer with detected molecular residual disease (MRD+) following standard neoadjuvant and locoregional therapy delivered with curative intent. In this study Patients will be treated with neratinib in addition to their standard T-DM1 adjuvant therapy. Neratinib will be administered orally at a dose of 160 mg daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from adding neratinib to their standard T-DM1 adjuvant therapy.

Eligible Conditions

  • Breast Cancer
  • HER2-positive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3 years

At week 12
Clearance of ctDNA with the addition of neratinib to trastuzumab-DM1 in patients with MRD detectable by the RaDaR assay, following standard neoadjuvant therapy, surgery, and initiation of T-DM1
Up to 3 years
Characterize dynamic changes and kinetics in ctDNA MRD+ for enrolled patients measured by ctDNA MRD Detection by RaDaR assay
Clinical outcomes for MRD+ patients treated with escalated strategy, including invasive breast cancer-free survival (IBCFS) measured by Invasive Breast Cancer-Free Survival and Distant Metastasis Free Survival
Toxicities of the combination of neratinib and trastuzumab-DM1 in the study population measured by CTCAE 5.0

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Breast Cancer

Side Effects for

N200 + C2000
100%Diarrhoea
67%Decreased appetite
50%Nausea
33%Thrombocytopenia
33%Dry skin
33%Mucosal inflammation
33%Activated partial thromboplastin time prolonged
33%Abdominal distension
33%Abdominal pain
33%Asthenia
17%Hyponatraemia
17%Back pain
17%Vomiting
17%Stomatitis
17%Haematuria
17%Hypoaesthesia
17%Febrile neutropenia
17%Alanine aminotransferase increased
17%Liver function test abnormal
17%Blood creatinine increased
17%Faeces soft
17%Seasonal allergy
17%Aspartate aminotransferase increased
17%Leukopenia
17%Skin infection
17%Dry mouth
17%Fatigue
17%Dysgeusia
17%Blood bilirubin increased
17%Hypomagnesaemia
17%Musculoskeletal chest pain
17%Pain in extremity
17%Anxiety
17%Shock haemorrhagic
17%Depression
17%Lymphoedema
17%Pyrexia
17%Monoparesis
17%Palmar-plantar erythrodysaesthesia syndrome
17%Rash
17%Abdominal pain upper
17%Cheilitis
17%Constipation
17%Haematemesis
17%Urinary tract infection
17%Disease progression
17%Spinal cord compression
17%Lymphopenia
17%Neutropenia
17%Hypotension
0%Oedema
0%Blood alkaline phosphatase increased
0%Gamma-glutamyltransferase increased
0%Muscular weakness
0%Neck pain
0%Insomnia
0%Dyspnoea
0%Hypokalaemia
0%Metrorrhagia
0%Pulmonary embolism
0%Pain
0%Inflammation
0%Accidental overdose
0%General physical health deterioration
0%Implant site pain
0%Respiratory tract infection
0%Electrocardiogram QT prolonged
0%Haemoglobin decreased
0%Nervous system disorder
0%Abdominal discomfort
0%Hypoglycaemia
0%Neurotoxicity
0%Proctitis
0%Nasopharyngitis
0%Paronychia
0%Ligament sprain
0%Neuralgia
0%Cough
0%Epistaxis
0%Onycholysis
0%Hyperbilirubinaemia
0%Dizziness
0%Blood lactate dehydrogenase increased
0%Pneumonia
0%Productive cough
0%Hyperhidrosis
0%Hyperphosphataemia
0%Dyspepsia
0%Headache
0%Ataxia
0%Cystitis
0%Rhinitis
0%Nerve root compression
0%Thrombosis
0%Hyperglycaemia
0%Muscle spasms
0%Ascites
0%Rhinorrhoea
0%Nail disorder
0%Nail dystrophy
0%Mouth ulceration
0%Oedema peripheral
0%Hypersensitivity
0%Influenza like illness
0%Candida infection
0%Gastrointestinal disorder
0%Radius fracture
0%Dehydration
0%Breast neoplasm
0%Early satiety
0%Injection site extravasation
0%Xerosis
0%Musculoskeletal pain
0%Myalgia
0%Balance disorder
0%Peripheral sensory neuropathy
0%Somnolence
0%Chills
0%Intestinal obstruction
0%Fall
0%Hypercholesterolaemia
0%Arthralgia
0%Posture abnormal
0%Breast swelling
0%Alopecia
0%Onychoclasis
0%Ureteric stenosis
0%Renal failure
0%Respiratory failure
0%International normalised ratio increased
0%Blood glucose increased
0%Weight increased
0%Dysarthria
0%Dermatitis
0%Acarodermatitis
0%Anaemia
0%Periorbital contusion
0%Neuropathy peripheral
0%Night sweats
0%Weight decreased
0%Impaired healing
0%Upper respiratory tract infection
0%Sinus congestion
0%Pericardial effusion
0%Vertigo
0%Tachycardia
0%Hypothyroidism
0%Lacrimation increased
0%Dental caries
0%Lip dry
0%Face injury
0%Lobar pneumonia
0%Gastroenteritis
0%Gastroenteritis viral
0%Nail infection
0%Small intestinal obstruction
0%Wound infection pseudomonas
0%Contusion
0%Melaena
0%Herpes zoster
0%Biloma
0%Femur fracture
0%Blood alkaline phosphatase abnormal
0%Breast pain
0%Convulsion
0%Calculus ureteric
0%Lacunar infarction
0%Hypoxia
0%Dysuria
0%Pigmentation disorder
0%Skin fissures
0%Skin lesion
0%Arteriosclerosis
0%Haemorrhage
0%Hypertension
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT00741260) in the N200 + C2000 ARM group. Side effects include: Diarrhoea with 100%, Decreased appetite with 67%, Nausea with 50%, Thrombocytopenia with 33%, Dry skin with 33%.

Trial Design

1 Treatment Group

Neratinib Arm
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Neratinib Arm · No Placebo Group · Phase 2

Neratinib Arm
Drug
Experimental Group · 1 Intervention: Neratinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
2014
Completed Phase 2
~1890

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: University Health Network: Princess Margaret Cancer Centre · Toronto, Canada
Photo of Toronto  1Photo of Toronto  2Photo of Toronto  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Breast Cancer
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for adjuvant radiation therapy.
You have no prior neratinib or other HER2 tyrosine kinase inhibitor ECOG performance status 0-1.
You have HER2 positive breast cancer, with residual invasive disease following prior neoadjuvant trastuzumab-based chemotherapy.
You have no contraindications to T-DM1 or neratinib.
You have received 2 or more cycles of trastuzumab-DM1 in the adjuvant setting.
You have received 12 weeks of endocrine therapy.
The [beta] HCG test must be negative.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.