Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer
HER2-positive Breast Cancer
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Neratinib escalation 2 weeks(group A)
Neratinib escalation 4 weeks(group B)
Neratinib standard dose control (group C)
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.
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.
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.