Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:

Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05154396
• Other study ID #: NCC3075
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan
• Phone: 01087787245
• Email: yuanpengyp01[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This is A prospective, randomized, single-center clinical trial, divided into 3 groups (experimental group: group A and group B, control group: group C), planned sixty patients were enrolled, with 20 patients in each group.

Experimental group: Group A (n=20) and group B (n=20) were given neratinib dose escalation regimen foranti-HER2 adjuvant therapy.In group A, the dose of neratinib climbed up to 240mg within 2 weeks, and in group B, the dose climbed up to 240mg within 4 weeks.

Control group: Group C (n=20) was given 240mg neratinib initially, but prophylactic loperamide antidiarrhea treatment was given at the same time within 2 months.

Diarrhea caused by neratinib often occurred within 1-2 months of initial treatment, so small dose of neratinib was used in both group A and group B at the time of initial treatment.

The incidence and severity of neratinib-related diarrhea in the three groups were observed, and DFS and other neratinib-related adverse events were followed up for a long time. The study is to evaluate the safety and efficacy of neratinib dose escalation regimen and conventional dose combined with loperamide regimen in enhanced anti-HER2 adjuvant therapy for early HER2-positive breast cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 ? ? ?, or initial stage (before neoadjuvant therapy) ? ? ?, 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Neratinib
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Endpoint	3-year invasive disease-free survival (iDFS%) and other safety events	up to 3 year after the last patient enrolled