Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Herbal and Botanical

Amino Acids

Capecitabine

Loperamide

Neratinib

Antidiarrheals

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Cola

Tyrosine

Neratinib with loperamide prophylaxis, and capecitabine for participants treated for metastatic breast cancer

Administered orally once daily as a single daily dose of 240 mg

Administered orally twice daily at 750 mg/m\^2 for 14 days of each 21 day treatment cycle

Administered orally for prophylaxis for 28 days and then as needed

Chief Scientific Officer

This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment.

This is an open-label, phase 2 study that will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib as monotherapy.

All patients will receive neratinib for the first 28 days as a single daily dose of 240 mg.

Colonoscopy will be performed after eligibility has been confirmed, but prior to administration of the first dose of neratinib and at Day 30 (± 3 days) the conclusion of Cycle 1 (28 days).

Following the second study colonoscopy procedure:

* For patients being treated for stage 1 to 3c breast cancer in the extended adjuvant setting, neratinib will continue to be administered at a single daily dose of 240 mg until completion of one year of therapy from start of treatment, or until disease recurrence (as determined by the Investigator), death, unacceptable toxicity, or other specified withdrawal criterion.
* For patients being treated for metastatic breast cancer (mBC), capecitabine will be introduced after the second study colonoscopy procedure at a dose of 750mg/m2 twice daily for 14 days of each 21 day treatment cycle, with neratinib administered continuously throughout at 240 mg daily, until disease progression, death, unacceptable toxicity, or other specified withdrawal criterion.

All patients will receive loperamide diarrhea prophylaxis daily for one 28-day cycle and then as needed.

A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

The primary endpoint is to describe the changes in colon pathology between the baseline colonoscopy and the second colonoscopy.

Incidence and severity of treatment emergent (TEAE) diarrhea will be summarized according to the NCI-CTCAE version 4.0 in the first cycle of neratinib treatment, which is from the time of the first colonoscopy to the second colonoscopy, or 28 days for subjects with only one colonoscopy. Incidence is defined as the number of patients experiencing diarrhea divided by the number of patients at risk.

Puma Biotechnology, Inc.

Safety population: Participants receiving at least 1 dose of investigational product.

Serious and Other Adverse Events were monitored/assessed only in the safety population

Safety

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Portugal

Region of Enrollment

Senior Director, Clinical Operations

No Significant Findings

Mild Changes

Subjects who had a baseline colonoscopy and a second colonoscopy with findings to report.

Neratinib Patients With 2 Colonoscopies

Changes in Colon Pathology

TEAE Diarrhea

Serious Diarrhea

Incidence and Severity of Diarrhea

Participants with stage 1 to 3c disease receiving extended adjuvant therapy are anticipated to participate in the study for approximately 1 year: 1 month for screening and 12 months of treatment, and 1 month of safety follow up.

Patients with mBC are anticipated to participate in the study for an average of 12 month: 1 month of screening, 9.5 months for treatment, and 1 month of safety follow up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib	NCT04366713	HER2 Amplified ...	Neratinib Capecitabine Loperamide	18 Years -	Puma Biotechnology, Inc.
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib	NCT04366713	HER2 Amplified ...	Neratinib Capecitabine Loperamide	18 Years -	Puma Biotechnology, Inc.

Spots Global Cancer Trial Database for colon pathology