Trastuzumab and Vinorelbine in Advanced Breast Cancer
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.
Metastatic Breast Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Objective Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- CTCs [ Time Frame: 2 years ] [ Designated as safety issue: No ]To describe the number of CTCs and the CTCs characteristics before and after therapy, and to explore the correlation of these findings with response.
- Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To further characterize the safety and tolerability of trastuzumab and vinorelbine in this patient population.
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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 needed.
- 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.
|Contact: Ian Krop, MD, PhDemail@example.com|
|Contact: Vivian Wangfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: Ian Krop, MD, PhD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Sub-Investigator: Gerburg Wulf, MD, PhD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Sub-Investigator: Steven Isakoff, MD, PhD|
|Dana-Farber Cancer Institute at Faulkner Hospital||Recruiting|
|Boston, Massachusetts, United States, 02130|
|Sub-Investigator: Erica Mayer, MD, MPH|
|Principal Investigator:||Ian Krop, MD, PhD||Dana-Farber Cancer Institute|