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.
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
406
Every week for 12 weeks
Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
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
...and 10 more locations
3-year Disease Free Survival (DFS) Rate
Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.
Time frame: at 3 years
Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm
DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
Time frame: at 3 years
Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction
cardiac left ventricular dysfunction related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
Time frame: AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
Number of Patients With Grade III/IV Neurotoxicity
Nervous system disorders related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.
Time frame: AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).
Number of Patients With Amenorrhea
Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.
Time frame: Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.
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