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Tyrosine Kinase Inhibitor

Neratinib for Breast Cancer (FACT-2 Trial)

Phase 2

Waitlist Available

Led By Gregory A Vidal, MD.,PhD

Research Sponsored by West Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary breast tumor palpable and ≥ 1.0 cm

Nodal status negative or positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Awards & highlights

FACT-2 Trial Summary

This trial is testing a new combination drug treatment for early stage triple-negative breast cancer patients who show enhanced HER2 signaling.

Who is the study for?

This trial is for women over 18 with early-stage triple-negative breast cancer that's HER2-negative, palpable and at least 1.0 cm large. They must have good performance status, adequate organ function, no history of certain cancers or treatments within the last two years, and agree to non-hormonal contraception during and post-treatment.Check my eligibility

What is being tested?

The study tests Neratinib's effectiveness when given before Paclitaxel and Carboplatin in patients whose tumors show enhanced HER2 signaling. It's an open-label Phase II trial where all participants receive the same treatment without a comparison group.See study design

What are the potential side effects?

Neratinib may cause diarrhea, liver issues, rash, stomach pain or upset. Paclitaxel can lead to hair loss, joint/muscle pain while Carboplatin might cause low blood counts increasing infection risk.

FACT-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast tumor can be felt and is at least 1 cm big.

Select...

My cancer may or may not have spread to my lymph nodes.

Select...

My tumor is between 1 cm and 5 cm in size.

Select...

My tumor is not HER2 positive.

Select...

I am fully active or can carry out light work.

Select...

I am eligible for weekly chemotherapy with paclitaxel and carboplatin.

Select...

My breast cancer was confirmed with a needle biopsy.

Select...

I am 18 years old or older.

Select...

My cancer has not spread to many lymph nodes.

FACT-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The percentage of patients experiencing ≥ 20% response to neratinib only therapy

rate of pathologic complete response (pCR)

Secondary outcome measures

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

+2 more

Side effects data

From 2022 Phase 2 trial • 11 Patients • NCT03094052

100%

Diarrhea

100%

Constipation

82%

Nausea

45%

Fatigue

45%

Abdominal distension

36%

Headache

36%

Dizziness

27%

Hot flashes

27%

Pruritus

27%

Dyspnea

27%

Weight loss

27%

Vomiting

27%

Anorexia

18%

Dysgeusia

18%

Alanine aminotransferase increased

18%

Aspartate aminotransferase increased

18%

Fever

18%

Gastrointestinal disorders - Other, specify

18%

Abdominal pain

18%

Bloating

18%

Sinus bradycardia

18%

Skin and subcutaneous tissue disorders - Other, specify

Anxiety

Cholecystitis

Mucositis oral

Paresthesia

Rash maculo-papular

Upper respiratory infection

Fracture

Back pain

Joint range of motion decreased

Vaginal dryness

Lymphedema

Anal hemorrhage

Muscle weakness upper limb

Musculoskeletal and connective tissue disorder - Other, specify

Vaginal hemorrhage

Chills

Vaginal discharge

Gastroesophageal reflux disease

Creatinine increased

Bruising

Vaginal infection

Arthralgia

Pain

Urinary tract pain

Wheezing

Ejection fraction decreased

Peripheral sensory neuropathy

Insomnia

Flatulence

Flu like symptoms

Rash acneiform

Oral dysesthesia

Stomach pain

General disorders and administration site conditions - Other, specify

Infections and infestations - Other, specify

Fall

Neck pain

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Neratinib)

FACT-2 Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neratinib

FDA approved

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celcuity, Inc.Industry Sponsor

6 Previous Clinical Trials

935 Total Patients Enrolled

3 Trials studying Breast Cancer

898 Patients Enrolled for Breast Cancer

Celcuity IncIndustry Sponsor

7 Previous Clinical Trials

989 Total Patients Enrolled

3 Trials studying Breast Cancer

898 Patients Enrolled for Breast Cancer

West Cancer CenterLead Sponsor

4 Previous Clinical Trials

568 Total Patients Enrolled

Frequently Asked Questions

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

How many people total can join this clinical trial?

"That is correct, the online clinicaltrial.gov registry confirms that this study is currently recruiting participants. The trial was first posted on 6/21/2019 and updated as recently as 10/9/2020. Currently, 27 more patients are needed at a single location."

Answered by AI

Are researchers looking for more participants in this clinical trial?

"Yes, this clinical trial is recruiting participants. The latest update on the study was on October 9th, 2020 and it was first posted June 21st, 2019 according to the information available on clinicaltrials.gov"

Answered by AI

Is there a high margin of error for Neratinib?

"There is some data supporting Neratinib's safety, but since this is a Phase 2 trial and there is no efficacy data yet, it received a score of 2."

Answered by AI

Does previous research support the use of Neratinib in this case?

"At this time, there are a total of 20 different clinical trials underway that are focusing on Neratinib. Of these active studies, 0 are in Phase 3. Out of the 130 locations running these trials, most are situated in Richmond, Virginia."

Answered by AI

What are the therapeutic goals of this scientific investigation?

"The primary objective of the study, which will be measured over a period of 15 weeks, is to determine the percentage of patients who respond to neratinib therapy. Additionally, the study will evaluate secondary outcomes including patient completion rates and residual cancer burden."

Answered by AI

Recent research and studies

BMC CancerJournal

Development of a Test That Measures Real-time HER2 Signaling Function in Live Breast Cancer Cell Lines and Primary Cells

Huang, Yao, David J. Burns, Benjamin E. Rich, Ian A. MacNeil, Abhijit Dandapat, Sajjad M. Soltani, Samantha Myhre, et al.. 2017. “Development of a Test That Measures Real-time HER2 Signaling Function in Live Breast Cancer Cell Lines and Primary Cells”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-017-3181-0.

OncotargetJournal

A Functional Signal Profiling Test for Identifying a Subset of Her2-negative Breast Cancers with Abnormally Amplified HER2 Signaling Activity

Huang, Yao, David J Burns, Benjamin E Rich, Ian A MacNeil, Abhijit Dandapat, Sajjad M. Soltani, Samantha Myhre, et al.. 2016. “A Functional Signal Profiling Test for Identifying a Subset of Her2-negative Breast Cancers with Abnormally Amplified HER2 Signaling Activity”. Oncotarget. Impact Journals, LLC. doi:10.18632/oncotarget.12480.

clinicaltrials.govStudy

Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

2019. "Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03812393.

All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer