Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Chinese Academy of Medical Sciences60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HER2-positive Breast Cancer

Interventions

NeratinibDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: up to 3 year after the last patient enrolled

Secondary Outcomes

Secondary Endpoint

3-year invasive disease-free survival (iDFS%) and other safety events

Time frame: up to 3 year after the last patient enrolled

Central Contacts

Peng Yuan

CONTACT

01087787245 yuanpengyp01@163.com

Xue Wang

CONTACT

01087787242 wxyxyuki@163.com

Data from ClinicalTrials.gov

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