A Phase II, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With HER2 Negative Primary Tumors and HER2 Positive Circulating Tumor Cells
- Participants will receive two different drugs. Trastuzumab will be administered by
vein every 3 weeks. Participants will receive a higher dose of trastuzumab on the
first day of treatment followed by a lower dose for subsequent administration.
Vinorelbine will be administered by vein once a week.
- Each treatment cycle lasts 3 weeks during which time participants will be receiving
Vinorelbine weekly and Trastuzumab every 3 weeks. Participants will continue to
receive Vinorelbine weekly and Trastuzumab every 3 weeks as long as their cancer is not
growing and they are not experiencing severe side effects.
- Circulating tumor cells (CTCs) will be collected at study entry, at 6 weeks or up to
one week prior, and when study treatment is stopped.
- ECHO or MUGA scan is performed at study entry and repeated at 18 weeks and then as
- CT or MRI will be performed at study entry and then repeated every 6 weeks for the
first 18 weeks and then every 12 weeks thereafter. A bone scan or CT/MRI scan of the
brain will be performed if the doctor determines this is medically necessary.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
To assess the objective response rate of trastuzumab and vinorelbine in patients with metastatic breast cancer with HER2 negative primary tumors and HER2 positive circulating cells.
Ian Krop, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana-Farber Cancer Institute at Faulkner Hospital||Boston, Massachusetts 02215|