NCT03085368

A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin

A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib and Paclitaxel vs Herceptin and Paclitaxel With Sequential and Synchronous Anthracycline

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 482 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline

Detailed description

This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline. Safety and efficacy are the primary endpoint. The positive expression of HER2 was confirmed by postoperative pathology in patients with breast adenocarcinoma (IDC). Patients who had not received any chemotherapy and targeted anti HER2 therapy. In this study, the non inferiority design method, according to the wishes of patients and signed informed consent, randomly into the group, a total of 482 patients were enrolled in the trial group: the control group =1:1. The subjects were followed up for a total of 1 years, until the disease progressed, and the toxicity was not tolerated. We want to study 84 months. The follow-up period was 5 years (the first adjuvant treatment time to the last follow-up) or the researchers decided to end the study.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	lapatinib/herceptin	Lapatinib produced by glaxosmithkline. Oral small molecule epidermal growth factor tyrosine kinase inhibitor. Mainly used for combined with capecitabine in the treatment of ErbB-2 over expression, including received prior anthracycline, paclitaxel and trastuzumab (Herceptin) in the treatment of advanced or metastatic breast cancer. Our clinical trial want to see its benefit in early breast cancer

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-05-01
• Completion: 2021-03-01
• First posted: 2017-03-21
• Last updated: 2017-07-28

Locations

1 site across 1 country: China