Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
This study will assess the usefulness of a technique called complementary deoxyribonucleic
acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated
patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study
will look for "markers" that can help select the most effective type of chemotherapy. It will
also evaluate the safety and effectiveness of a new drug combination of capecitabine and
docetaxel.
Patients age 18 years and older with stage II or III breast cancer whose tumor is 2
centimeters or larger may be eligible for this study. Those enrolled will be treated with
surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan),
and the capecitabine and docetaxel combination.
Patients will have a physical examination, mammogram and magnetic resonance imaging to
evaluate their tumor before beginning treatment. They will then have four 21-day treatment
cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on
day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be
given from days 16 through 21. This regimen will be repeated four times, after which the
tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance
imaging.
Patients will then have surgery to remove the cancer-either lumpectomy with removal of the
underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical
mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a
doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four
21-day cycles.
Some patients who had a mastectomy (depending on their tumor characteristics and whether
tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also
have radiation therapy. Patients with hormone receptor-positive tumors will also receive
tamoxifen treatment for 5 years.
In addition to the above procedures, all patients will have tumor biopsies (removal of a
small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2,
and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized
tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear
medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood
tests at various times during the study. Patients will be followed at National Institutes of
Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and
computed tomography (CT) scans.
Although it is not known whether this treatment will help an individual patient's cancer,
possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition,
the information gained about genetic changes after chemotherapy will help determine if
additional studies on the use of cDNA microarray to measure tumor response are warranted.