Trastuzumab and Vinorelbine in Advanced Breast Cancer

Phase 2 Terminated 31 enrolled Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center · collab Brigham and Women's Hospital · collab Genentech, Inc. · collab Massachusetts General Hospital · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called HER2. Trastuzumab is an FDA approved drug that targets HER2. The drug combination of trastuzumab and vinorelbine is an effective treatment for patients with breast cancers that are positive for HER2. This trial seeks to determine if the combination can also benefit participants whose original breast cancer was HER2 negative but whose circulating tumor cells are HER2 positive.

Timeline

Start: 2010-11
Primary completion: 2017-01
Completion: 2018-01

Outcome

Outcome not reported

Stopped: “Not enough confirmed responses to continue treatment.”

Publications

Parsons HA, Macrae ER, Guo H, Li T, Barry WT, Tayob N, Wulf GM, Isakoff SJ, Krop IE. Phase II Single-Arm Study to Assess Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2-Negative Tumors and HER2-Positive Circulating Tumor Cells. JCO Precis Oncol. 2021 Nov;5:896-903. doi: 10.1200/PO.20.00461.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Vinorelbine	Small molecule	25 mg/kg	Intravenous