Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
Participants will receive Herceptin in addition to chemotherapy with Taxol and FEC. 'FEC' is
Fluorouracil, Cyclophosphamide and Epirubicin.
During the first course of therapy Herceptin will be given on day 1 through a needle in a
vein over 90 minutes. Participants will then be observed for 1 hour after that for harmful
side effects. If none occur, later doses of Herceptin will be given over 30 minutes instead
of 90 minutes.
On day 2, participants will be given Taxol again through a needle in a vein over 24 hours.
Participants will receive the drugs Decadron (dexamethasone), Benadryl (diphenhydramine) and
Tagamet (cimetidine) prior to Taxol treatment to prevent allergic reaction due to Taxol.
Participants will be observed for 1 hour after starting Taxol for harmful side effects. If
none occur, both Taxol and Herceptin can be given on the same day on subsequent courses.
Taxol will be premedicated with the same drugs on subsequent courses.
Participants will receive Herceptin weekly for 24 consecutive weeks. Taxol will be given to
participants every 3 weeks for 4 courses.
Participants who get a fever or infection during treatment may be given the drug G-CSF.
Granulocyte colony-stimulating factor (G-CSF or GCSF) stimulates the bone marrow to make
white blood cells, which fight infections.
After Taxol treatment, all participants will receive the drugs fluorouracil,
cyclophosphamide, and epirubicin (FEC) through a plastic tube in a vein. Fluorouracil will
be given intravenously (IV) as a short infusion on days 1 and 4. Cyclophosphamide will be
given intravenously as a short infusion on day 1. Epirubicin will be given IV on day 1.
This FEC treatment will be repeated every 3 weeks for a total of 4 treatments. Participants
will continue to receive Herceptin weekly during therapy with FEC.
After all FEC treatment is done and surgery is completed, patients with tumors that are
sensitive to hormones will begin taking the drug tamoxifen and/or aromatase inhibitors if
the patient is postmenopausal. The drug will be given as a pill once a day for 5 years.
Patients will then 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 be removed. Patients may then receive radiation treatment to the breast area and
armpit once a day for six weeks.
During the study, participants will have blood tests once a week during the first course of
treatment of both Taxol and FEC. In subsequent courses, blood tests will be done prior to
administration of chemotherapy. A mammogram and a sonogram will be obtained after Taxol
treatment and after FEC treatment. This will help doctors keep track of the tumor size and
decide whether to remove all or part of the breast and nearby lymph nodes.
After the study, participants will return for checkups every 4 months during years 1 and 2,
every 6 months during year 3, and once a year after that. At each visit, participants will
have a complete exam including blood tests and a chest x-ray. Mammography will be done once
Before the study, participants will have a complete exam including blood tests and a chest
x-ray. A mammogram and a sonogram of the breast and armpit will be obtained to record tumor
size. Small metal clips will be inserted into the breast to mark the tumor if the tumor is
shrinking rapidly in response to therapy; in this way, if the tumor disappears after drug
treatment, the surgeon can still remove the tissue around the tumor. Sonography of the
liver or a CT scan of the abdomen will also be done. In some participants, 3-4 samples of
the breast that has tumor will be taken. The samples will be taken using a biopsy needle.
An echocardiogram (heart function test) will be done on every participant at baseline. An
echocardiogram will be done after finishing their Taxol chemotherapy and another one after
finishing FEC chemotherapy. Copies of the echocardiogram tapes may be sent to the sponsor
for review. Women who are able to have children will have a pregnancy test.
After having completed therapy, all patients will have a follow-up evaluation of their heart
function (same as baseline) 4 months or greater after last treatment.
This is an investigational study. Taxol and Herceptin and all other drugs used in this
study are approved by the U. S. Food and Drug Administration. All patients will be treated
in the MD Anderson Cancer Center outpatient clinic.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Achieved Pathological Complete Remission
Response criteria for Complete Remission defined as disappearance of all clinical evidence of active tumor by clinical evaluation, mammogram and/or ultrasound, and free of all symptoms.
Baseline to last treatment cycle (approximately 28 weeks, 4 cycles of 21-day intervals of Taxol and up to 4 cycles of FEC for 3-4 week intervals)
Aman U Buzdar, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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