Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
Before the study, participants will have a complete physical exam, including blood tests and
a chest x-ray. A mammogram and a sonogram of the breast and armpit will be done to record
tumor size (for patients who have not had surgery). Sonography of the liver or a CT scan of
the abdomen will also be done. In some patients who have not had surgery, 3-4 samples of the
breast tumor will be taken to help confirm the diagnosis of breast cancer. A biopsy needle
will be used to collect the samples.
During the study, participants will have blood tests done before each dose of chemotherapy.
For participants who have not had surgery, a mammogram and sonogram will be done of the
breast and armpit after completion of paclitaxel or docetaxel/capecitabine and after
completion of fluorouracil, cyclophosphamide, and epirubicin (FEC). These studies will help
doctors to keep track of the tumor size and help with the final decision whether to remove
all or part of the breast and nearby lymph nodes after completion of chemotherapy.
Participants in this study will be randomly assigned (as in the toss of a coin) to one of
two treatment groups. There is an equal chance of being in either group.
Participants in Group I will receive paclitaxel once a week. The drug will be given through
a plastic tube in a vein over 1 hour for a total of 12 treatments. Before each treatment,
patients will receive the drug Decadron (dexamethasone) through the vein and may receive
Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride) and/or cimetidine to help
decrease the risk of side effects from paclitaxel.
Participants in Group II will receive docetaxel and capecitabine. Docetaxel will be given
once every 3 weeks. Docetaxel will be given through a plastic tube in the vein over 1 hour.
Capecitabine will be started the same day docetaxel is given. This medicine is given in a
pill form. The doctor will prescribe a dose of these pills based upon body weight and
height. Participants will take several pills two times a day for 14 days. Participants will
then not take any capecitabine pills for one week, until the next dose of docetaxel is
given. This combination of docetaxel and capecitabine will be given four times (over a
period of 12 weeks). Before each treatment, patients will receive the drug Decadron
(dexamethasone) by mouth.
After treatment with either paclitaxel or docetaxel/capecitabine, all participants will
receive the drugs FEC through a plastic tube into a vein. All of these drugs will be given
once every three weeks for a total of 4 treatments (12 weeks total). Decadron
(dexamethasone), Zofran (ondansetron) and Benadryl (diphenhydramine hydrochloride) will be
given before the chemotherapy to help decrease the risk of side effects.
Participants who have a Her-2/neu positive cancer will potentially be eligible to receive
trastuzumab therapy for 1 year. This medicine is given through a vein either once a week
(over 30 minutes) or once every 3 weeks (over 30 minutes). Your doctor will discuss whether
this medicine is appropriate for you.
After all treatment is done, participants whose tumors are sensitive to hormones (estrogen)
will take a pill to help decrease the amount of hormone (estrogen) that can reach any tumor
cells. This pill will be taken once a day for 5 years.
Participants who have not completed surgery for their cancer before receiving the
chemotherapy described above will have surgery to remove all or part of the breast that has
cancer. If there are signs that the lymph nodes in the armpit (axilla) contain cancer, these
lymph nodes will also be removed.
After chemotherapy and surgery, or after completion of chemotherapy (patients who had
surgery done first), participants may then receive radiation treatment to the breast area
and armpit once a day (Monday through Friday) for 5-6 weeks.
After the study, participants will return for checkups every 3-4 months during Years 1 and
2, every 6 months during years 3 and 4 and yearly after that. During the check-ups
participants will talk with and be examined by their physician. Once a year, patients will
have yearly mammograms (as needed), chest-x rays, and blood tests.
This is an investigational study. All of the drugs in this study are approved by the FDA
for treatment of breast cancer. A total of 930 patients will take part in this study. All
will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Reoccurrence
Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).
Median of 50 months
Aman U. Buzdar, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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