Spots Global Cancer Trial Database for Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
Official Title: A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
Study ID: NCT00542451
Study Description
Brief Summary: The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.
Detailed Description: * Participants will enroll in this study at the time they are starting their adjuvant therapy for breast cancer. Participants will receive chemotherapy with paclitaxel every week for 12 weeks. They will begin to receive trastuzumab at the same time they begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab, they will receive trastuzumab every 3 weeks or weekly for 40 weeks. * Participants will be followed with routine assessments such as physical exam and vital signs every 3 months for the first year, and then every 6 months for years 2-5. Then we would like to keep track of the participants medical condition by calling them on the telephone once per year.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of California-San Francisco, San Francisco, California, United States
Loyola University Medical Center, Maywood, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
John Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber at Faulkner Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Cape Cod Healthcare, Hyannis, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
North Shore Medical Center, Peabody, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
North Shore LIJ Health System Monter Cancer Center, Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Case Western University, Cleveland, Ohio, United States
Tennessee Oncology, Nashville, Tennessee, United States
University of Vermont Cancer Center, Burlington, Vermont, United States
Contact Details
Name: Sara Tolaney, MD, MPH
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
