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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

Must not have

Synchronous bilateral invasive breast cancer

Previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 targeted therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial tests a treatment for early-stage triple-negative breast cancer patients with abnormal HER2 signaling. The treatment starts with neratinib, a drug that blocks cancer growth signals, followed by a combination of neratinib and two chemotherapy drugs, paclitaxel and carboplatin. The goal is to see if this approach leads to better outcomes than standard treatments.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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My tumor is not HER2 positive.

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I am fully active or can carry out light work.

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I am eligible for weekly chemotherapy with paclitaxel and carboplatin.

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My breast cancer was confirmed with a needle biopsy.

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I am 18 years old or older.

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My cancer has not spread to many lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer in both breasts at the same time.

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I have been treated with drugs like anthracycline, taxanes, or HER2 targeted therapies.

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I had a lump or part of my breast removed before starting chemotherapy.

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My high blood pressure is not under control.

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I have active hepatitis B or C with abnormal liver tests.

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I do not have any chronic diseases that would interfere with treatment.

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My breast cancer is at an advanced stage or is inflammatory.

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I have a moderate to severe nervous system disorder.

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My breast cancer was diagnosed with a needle biopsy.

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My cancer has spread to other parts of my body.

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I cannot take corticosteroids due to my health condition.

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I have had breast cancer or DCIS on the same side before.

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I had a surgery to check lymph nodes in my armpit before starting chemotherapy.

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I am currently on antibiotics for a long-term infection.

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I have a lung condition that makes it hard for me to breathe.

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I take 10 mg or more of corticosteroids daily.

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My diabetes is not well-managed.

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I am currently on sex hormone therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

rate of pathologic complete response (pCR)

Secondary study objectives

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%

Abdominal distension

45%

Fatigue

36%

Dizziness

36%

Headache

27%

Dyspnea

27%

Hot flashes

27%

Anorexia

27%

Vomiting

27%

Pruritus

27%

Weight loss

18%

Skin and subcutaneous tissue disorders - Other, specify

18%

Dysgeusia

18%

Bloating

18%

Fever

18%

Abdominal pain

18%

Gastrointestinal disorders - Other, specify

18%

Aspartate aminotransferase increased

18%

Alanine aminotransferase increased

18%

Sinus bradycardia

Back pain

Muscle weakness upper limb

Neck pain

Rash acneiform

Lymphedema

Rash maculo-papular

Vaginal dryness

Anal hemorrhage

Paresthesia

Gastroesophageal reflux disease

Pain

Infections and infestations - Other, specify

Urinary tract pain

Flu like symptoms

Fracture

Flatulence

Mucositis oral

Chills

General disorders and administration site conditions - Other, specify

Ejection fraction decreased

Oral dysesthesia

Peripheral sensory neuropathy

Creatinine increased

Upper respiratory infection

Vaginal infection

Stomach pain

Bruising

Fall

Joint range of motion decreased

Musculoskeletal and connective tissue disorder - Other, specify

Arthralgia

Vaginal discharge

Vaginal hemorrhage

Wheezing

Anxiety

Insomnia

Cholecystitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Neratinib)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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 / 27Eligibility criteria met