Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

NCT05154396 | Unknown Phase 2

• 1 other identifier: NCC3075
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective study on the prevention of Neratinib-related diarrhea in a Chinese population, exploring the best options for reducing the incidence of neratinib-related diarrhea through either pharmacologic intervention (prophylactic antidiarrheal therapy) or non-pharmacologic intervention (dose escalation program).

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Incidence of grade ≥3 diarrhea in patients with her2-positive early breast cancer treated with neratinib dose escalation versus neratinib conventional dose combined with loperamide

  up to 3 year after the last patient enrolled

Secondary Outcomes (1)

• Secondary Endpoint

  up to 3 year after the last patient enrolled

Study Arms (3)

Neratinib escalation 2 weeks（group A）

EXPERIMENTAL

Neratinib: 120mg/ day for days 1-7, 160mg/ day for days 8-14, and then 240mg/ day to complete 1-year treatment, or to tumor recurrence and metastasis, new breast cancer, or unacceptable adverse reactions within 1 year.

Drug: Neratinib

Neratinib escalation 4 weeks（group B）

EXPERIMENTAL

Neratinib: 160mg/ day for days 1-14, 200mg/ day for days 15-28, and then 240mg/ day for 1 year, or to tumor recurrence and metastasis, new breast cancer, or unacceptable adverse reactions within 1 year.

Drug: Neratinib

Neratinib standard dose control （group C）

PLACEBO COMPARATOR

Neratinib: 240mg/ day for 1 year, or to tumor recurrence and metastasis, new breast cancer or unacceptable adverse reactions within 1 year. Loperamide prophylaxis: 4mg three times daily on days 1-14 and 4mg twice daily on days 15-56, followed by as needed, not exceeding 16mg/ day.

Drug: Neratinib

Interventions

Neratinib DRUG

Patients with her2-positive early breast cancer were treated with a dose escalation regimen of neratinib or a routine dose of neratinib combined with loperamide

Also known as: Loperamide prophylaxis

Neratinib escalation 2 weeks（group A）; Neratinib escalation 4 weeks（group B）; Neratinib standard dose control （group C）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 year-old women；
• ECOG score: 0-1；
• HER2 positive breast cancer diagnosed histologically is defined as HER2 (3+) by immunohistochemistry or HER2 (2+) with positive FISH test；
• Postoperative pathological stage ⅱ → ⅲ, or initial stage (before neoadjuvant therapy) ⅱ → ⅲ, radiographic assessment showed no metastasis;
• Complete 1 year of anti-HER2 therapy with trastuzumab, prior use of pertuzumab neoadjuvant + adjuvant therapy or T-DM1 adjuvant therapy is permitted;
• No major organ dysfunction, contraception;
• The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.

You may not qualify if:

• Patients who are allergic to the study drug, cannot take the drug orally, or refuse the medication regimen;
• Prior treatment with TKI anti-HER-2 drugs (e.g. Lapatinib, Pyrotinib, etc.);
• Patients were enrolled in other studies or stopped taking other drugs within 4 weeks;
• Patients with serious dysfunction of important organs (heart, liver and kidney);
• Patients with other malignancies, other than cured non-melanoma skin cancer, carcinoma in situ of the cervix and other tumors that have been cured for at least 5 years;
• In pregnancy, lactation patients;
• In the active stage of other acute or chronic infectious diseases;
• The patients have uncontrollable mental illness;
• There is a known history of human immunodeficiency virus;
• There are other circumstances in which the investigator suggested that the patient should not participate in the study.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

MeSH Terms

Interventions

neratinib

Study Officials

• Peng Yuan

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan

CONTACT

01087787245; yuanpengyp01@163.com

Xue Wang

CONTACT

01087787242; wxyxyuki@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of VIP department

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: December 13, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 13, 2021

Record last verified: 2021-11