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Kadcyla + Neratinib for Breast Cancer

Phase 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients ≥ 18 years of age with histologically confirmed, resected HER2 positive stage I-III breast cancer, with residual invasive disease following prior neoadjuvant trastuzumab (+/- pertuzumab)-based chemotherapy
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing whether adding neratinib to standard T-DM1 adjuvant therapy improves outcomes for patients with resected Stage I-III HER2+ breast cancer who have molecular residual disease.

Who is the study for?
This trial is for adults over 18 with HER2+ stage I-III breast cancer, who've had surgery and are on T-DM1 therapy but still show signs of cancer at a molecular level. They should be in good health otherwise, able to follow the study plan, and willing to use effective birth control.Check my eligibility
What is being tested?
The trial tests if adding neratinib (a pill taken daily) to standard T-DM1 therapy can clear remaining cancer traces after initial treatment. It's given for up to a year unless there's recurrence or side effects leading to stopping the drug.See study design
What are the potential side effects?
Neratinib may cause diarrhea, liver issues, rash, stomach pain, nausea, vomiting. Side effects vary by individual and some may require medical attention or discontinuation of the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18, had breast cancer surgery, and still have cancer after treatment with trastuzumab.
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I am willing and able to follow the study's treatment plan and attend all visits.
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I have no known allergies or adverse reactions to T-DM1 or neratinib.
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I had radiation therapy but it ended at least 14 days ago.
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I have been on hormone therapy for my cancer for at least 12 weeks.
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I am taking T-DM1 for cancer and still have minimal residual disease after 2-6 cycles.
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I am a man and I agree to use effective birth control.
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My organs are functioning well.
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I am fully active or can carry out light work.
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I have received 2-6 cycles of a specific cancer drug after surgery.
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My cancer has not returned or spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Side effects data

From 2022 Phase 2 trial • 11 Patients • NCT03094052
100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Fatigue
45%
Abdominal distension
36%
Dizziness
36%
Headache
27%
Anorexia
27%
Hot flashes
27%
Dyspnea
27%
Pruritus
27%
Weight loss
27%
Vomiting
18%
Aspartate aminotransferase increased
18%
Fever
18%
Skin and subcutaneous tissue disorders - Other, specify
18%
Alanine aminotransferase increased
18%
Bloating
18%
Dysgeusia
18%
Abdominal pain
18%
Gastrointestinal disorders - Other, specify
18%
Sinus bradycardia
9%
Vaginal hemorrhage
9%
Upper respiratory infection
9%
Mucositis oral
9%
Peripheral sensory neuropathy
9%
Anxiety
9%
Flu like symptoms
9%
Pain
9%
Infections and infestations - Other, specify
9%
Lymphedema
9%
Back pain
9%
Insomnia
9%
Fracture
9%
Bruising
9%
Wheezing
9%
Oral dysesthesia
9%
General disorders and administration site conditions - Other, specify
9%
Fall
9%
Urinary tract pain
9%
Ejection fraction decreased
9%
Neck pain
9%
Gastroesophageal reflux disease
9%
Joint range of motion decreased
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Cholecystitis
9%
Anal hemorrhage
9%
Chills
9%
Vaginal infection
9%
Rash maculo-papular
9%
Stomach pain
9%
Flatulence
9%
Paresthesia
9%
Creatinine increased
9%
Rash acneiform
9%
Arthralgia
9%
Muscle weakness upper limb
9%
Vaginal discharge
9%
Vaginal dryness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neratinib ArmExperimental Treatment1 Intervention
Standard T-DM1 (3.6mg/kg) IV infusion every 3 weeks administered with Neratinib (160 mg) orally once daily up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,463 Previous Clinical Trials
483,516 Total Patients Enrolled
53 Trials studying Breast Cancer
29,087 Patients Enrolled for Breast Cancer

Media Library

Neratinib Clinical Trial Eligibility Overview. Trial Name: NCT05388149 — Phase 2
Breast Cancer Research Study Groups: Neratinib Arm
Breast Cancer Clinical Trial 2023: Neratinib Highlights & Side Effects. Trial Name: NCT05388149 — Phase 2
Neratinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388149 — Phase 2

Frequently Asked Questions

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

Has Neratinib received authorization from the FDA?

"There is only limited clinical data indicating the safety of Neratinib, leading to a score of 2. No studies have yet proven its efficacy."

Answered by AI

Are there any opportunities for new patients to join this clinical trial?

"Confirmation can be found on clinicaltrials.gov that this study, first posted on November 1st 2022 and most recently updated October 31st 2022, is not currently recruiting patients. However, there are 2607 other trials actively searching for participants at the present time."

Answered by AI
~7 spots leftby Jul 2025