Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Loperamide

Criteria

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 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.

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.