Neratinib for Triple Negative Breast Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
West Cancer Center, Germantown, TN
Triple Negative Breast Neoplasms+4 More
Neratinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Triple Negative Breast Neoplasms

Study Summary

This study is evaluating whether a drug may help treat triple negative breast cancer.

See full description

Eligible Conditions

  • Triple Negative Breast Neoplasms
  • Breast Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Early-stage Breast Cancer
  • HER2-positive Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Neratinib will improve 2 primary outcomes and 5 secondary outcomes in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of 4 weeks.

15 weeks
Clinical complete response (cCR)
Increase in the number of patients completing neratinib prescription with the use of web based symptom monitoring
Residual cancer burden (RCB) 0-1
Safety and Toxicity per NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
The PCR rate in patients experiencing greater than or equal to 20% reduction in tumor volume following treatment with neratinib only in cycle 1.
rate of pathologic complete response (pCR)
4 weeks
The percentage of patients experiencing ≥ 20% response to neratinib only therapy

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

N240 + C2000
Diarrhoea
100%
Decreased appetite
75%
Palmar-plantar erythrodysaesthesia syndrome
75%
Vomiting
50%
Asthenia
50%
Nausea
50%
Weight increased
25%
Accidental overdose
25%
Lymphopenia
25%
Cough
25%
Nail infection
25%
Hypercholesterolaemia
25%
Fatigue
25%
Muscular weakness
25%
Lacrimation increased
25%
Mucosal inflammation
25%
Lip dry
25%
Upper respiratory tract infection
25%
Blood alkaline phosphatase increased
25%
Rhinorrhoea
25%
Skin lesion
25%
Anxiety
25%
Nail dystrophy
25%
Activated partial thromboplastin time prolonged
25%
Weight decreased
25%
Onycholysis
25%
Oedema peripheral
25%
Thrombocytopenia
25%
Pyrexia
25%
Candida infection
25%
Contusion
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
25%
Gamma-glutamyltransferase increased
25%
Hyperglycaemia
25%
Hypomagnesaemia
25%
Pigmentation disorder
25%
Posture abnormal
0%
Early satiety
0%
Hypoaesthesia
0%
Dyspnoea
0%
Dry skin
0%
Hyperbilirubinaemia
0%
Disease progression
0%
Blood alkaline phosphatase abnormal
0%
General physical health deterioration
0%
Proctitis
0%
Calculus ureteric
0%
Femur fracture
0%
Hypokalaemia
0%
Lacunar infarction
0%
Shock haemorrhagic
0%
Hypotension
0%
Thrombosis
0%
Inflammation
0%
Gastroenteritis
0%
Skin infection
0%
Blood glucose increased
0%
Arthralgia
0%
Muscle spasms
0%
Pain in extremity
0%
Dysarthria
0%
Neurotoxicity
0%
Depression
0%
Night sweats
0%
Gastroenteritis viral
0%
Haematuria
0%
Dermatitis
0%
Melaena
0%
Abdominal pain
0%
Ascites
0%
Ligament sprain
0%
Electrocardiogram QT prolonged
0%
Back pain
0%
Dizziness
0%
Neuralgia
0%
Breast swelling
0%
Epistaxis
0%
Productive cough
0%
Arteriosclerosis
0%
Nail disorder
0%
Lymphoedema
0%
Breast neoplasm
0%
Cystitis
0%
Acarodermatitis
0%
Ataxia
0%
Insomnia
0%
Skin fissures
0%
Anaemia
0%
Febrile neutropenia
0%
Pericardial effusion
0%
Pulmonary embolism
0%
Leukopenia
0%
Influenza like illness
0%
Pain
0%
Paronychia
0%
Wound infection pseudomonas
0%
Liver function test abnormal
0%
Hypoglycaemia
0%
Onychoclasis
0%
Vertigo
0%
Dehydration
0%
Dental caries
0%
Small intestinal obstruction
0%
Abdominal discomfort
0%
Blood lactate dehydrogenase increased
0%
Hyperphosphataemia
0%
Somnolence
0%
Metrorrhagia
0%
Hyperhidrosis
0%
Tachycardia
0%
Breast pain
0%
Hypothyroidism
0%
Cheilitis
0%
Dry mouth
0%
Dyspepsia
0%
Stomatitis
0%
Xerosis
0%
Respiratory tract infection
0%
Headache
0%
Convulsion
0%
Renal failure
0%
Oedema
0%
Seasonal allergy
0%
Fall
0%
Blood bilirubin increased
0%
Musculoskeletal chest pain
0%
Dysgeusia
0%
Dysuria
0%
Haemorrhage
0%
Hypersensitivity
0%
Blood creatinine increased
0%
Sinus congestion
0%
Radius fracture
0%
Spinal cord compression
0%
Abdominal distension
0%
Chills
0%
Urinary tract infection
0%
Face injury
0%
Nervous system disorder
0%
Haematemesis
0%
Pneumonia
0%
Herpes zoster
0%
Ureteric stenosis
0%
Nerve root compression
0%
Hypoxia
0%
Respiratory failure
0%
Neutropenia
0%
Abdominal pain upper
0%
Constipation
0%
Faeces soft
0%
Gastrointestinal disorder
0%
Mouth ulceration
0%
Intestinal obstruction
0%
Impaired healing
0%
Implant site pain
0%
Injection site extravasation
0%
Lobar pneumonia
0%
Nasopharyngitis
0%
Rhinitis
0%
Periorbital contusion
0%
Haemoglobin decreased
0%
International normalised ratio increased
0%
Hyponatraemia
0%
Musculoskeletal pain
0%
Neck pain
0%
Myalgia
0%
Balance disorder
0%
Monoparesis
0%
Neuropathy peripheral
0%
Peripheral sensory neuropathy
0%
Alopecia
0%
Rash
0%
Hypertension
0%
Biloma
0%
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT00741260) in the N240 + C2000 ARM group. Side effects include: Diarrhoea with 100%, Decreased appetite with 75%, Palmar-plantar erythrodysaesthesia syndrome with 75%, Vomiting with 50%, Asthenia with 50%.

Trial Design

2 Treatment Groups

Control
Treatment

This trial requires 27 total participants across 2 different treatment groups

This trial involves 2 different treatments. Neratinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment
Drug
TNBC patients with HER2 signal positive are treated with neratinib for 3 weeks followed by 12 weeks of neratinib in combination with weekly paclitaxel and carboplatin
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 weeks for reporting.

Closest Location

West Cancer Center - Germantown, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 6 weeks prior to initiating chemotherapy. If suspicious or abnormal, FNA or core biopsy is recommended, also within 6 weeks prior to initiating chemotherapy. Findings of these evaluations will be used to determine the nodal status prior to initiating chemotherapy.
The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and i institutional guidelines for the pre-entry research core biopsy for CELx HSF testing and for initiating chemotherapy
Patients must be female.
Patients must be ≥ 18 years old.
Patient must have an ECOG performance status of 0 or 1
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
The primary breast tumor must be palpable and measure ≥ 1.0 cm on physical exam.
The regional lymph nodes can be cN0 or cN1
The tumor size can be T1c or T2
Nodal status - negative

Patient Q&A Section

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

What are the signs of triple negative breast neoplasms?

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The present report suggests that not only ER and ALK positivity, but also p16(INK4a) and PTEN gene alteration are associated with luminal B subtype TNBC. A larger multicenter study is required to confirm our results and assess predictive factors.

Unverified Answer

Can triple negative breast neoplasms be cured?

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Patients with a [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer) have a better chance of not relapsing with the use of postoperative radiotherapy, although the difference was not as great as with metastasising breast cancer. The overall survival was similar to metastatic breast cancer; however, the patients were not so well with the triple negative breast cancer, and it was a big problem for their survival overall. Patients did not have the chance of having a lumpectomy-spare mastectomy, because this type of mastectomy was not used in the previous times.

Unverified Answer

What are common treatments for triple negative breast neoplasms?

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Triple negative breast cancer frequently remains incurable, so patients have a better prognosis with treatments that prevent metastases in other regions. Common treatments for triple negative breast cancer include chemotherapy and hormone therapies.

Unverified Answer

What causes triple negative breast neoplasms?

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TNBC may have multiple etiologies that may arise at the same time. The combination of genetic and epigenetic alterations of cell cycle progression genes suggest that these events do occur together and precede TNBC.

Unverified Answer

What is triple negative breast neoplasms?

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TNBC is an aggressive disease. Clinically, breast cancer can be divided into ER+ and ER- phenotype and TP53 is inactivated in about half of the TNBC cases.

Unverified Answer

How many people get triple negative breast neoplasms a year in the United States?

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The American Cancer Society estimates that 665,710 people will be diagnosed with TNBC by the end of 2018. In 2011, about 38 people were diagnosed per 100,000 with TNBC.

Unverified Answer

Who should consider clinical trials for triple negative breast neoplasms?

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Clinical trials for TNBCs have not had a significant effect on outcome. Clinical trials conducted for the purpose of obtaining clinical information about patients with TNBCs have not had a significant effect on their outcomes. Therefore, patients with TNBCs should be advised against trials designed to detect clinical prognostic factors for TNBCs.

Unverified Answer

Have there been other clinical trials involving neratinib?

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Results from a recent clinical trial of the current study demonstrate the ability of Neratinib to inhibit the ERBB2-driven signalling that is crucial for human breast cancer cell growth and provide preclinical rationale for a phase I clinical study with Neratinib in patients with advanced breast cancer.

Unverified Answer

What is the average age someone gets triple negative breast neoplasms?

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The average age of patients who develop TNBC is 44 +/- 15 years, which is just a little older than their male counterparts (41 +/- 6 years). On an incidence basis TNBC have a higher incidence rate than the other 3 variants, particularly in the elderly who are often diagnosed at an earlier stage. However, in countries such as the UK that have universal healthcare services, the incidence rates of TNBC are much less.

Unverified Answer

Does triple negative breast neoplasms run in families?

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Results from a recent clinical trial population, 20% had a family history of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and/or were BRCA2 positive, while 16% had germline BRCA1 mutations. Among triple negative breast neoplasms, 40% had a germline BRCA1 mutation and 53% had a BRCA2 deletion. This is higher proportion of triple negative breast neoplasms with [BRCA1] deletions than previously reported.

Unverified Answer

What are the common side effects of neratinib?

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Based on this analysis, treatment-related side effects can be classified into 4 categories. Neratinib-induced toxicity can be minimized by an individualized adjustment of therapy based on side effects.

Unverified Answer

How quickly does triple negative breast neoplasms spread?

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The mean rate of spread of TNBC was 4.1 mm/yr in our study. This rate is slower than the 4-hour spread rate of breast cancer in general. We find no justification for delaying local treatment for patients with TNBC if this is not the intent as long as there is no indication for chemotherapy. Patients’ treatment decisions should be based on a person’s willingness to accept a local treatment alternative rather than what treatment might have been avoided. Recent findings were based on a large number of tumors, and our results are only applicable to the time period analyzed.

Unverified Answer
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