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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038402 |
Purpose
The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer.
Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Herceptin Drug: Taxol Drug: Fluorouracil Drug: Cytoxan Drug: Epirubicin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer |
| Estimated Enrollment: | 164 |
| Study Start Date: | April 2001 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Herceptin + Taxol Followed by FEC: Experimental |
Drug: Herceptin
Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.
Drug: Taxol
225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.
Drug: Fluorouracil
500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.
Drug: Cytoxan
500 mg/m^2 on Day 1 of each cycle for 4 cycles.
Drug: Epirubicin
75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.
|
Hide Detailed DescriptionParticipants 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. G-CSF 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 a year.
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 outpatient clinic.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Aman U Buzdar, MD | 713-792-2817 |
| United States, Texas | |
| The University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Deborah Francis, RN 713-792-2817 | |
| Contact: Debra Frye, RN 713-792-2817 | |
| Principal Investigator: Aman U Buzdar, MD | |
| Principal Investigator: | Aman U Buzdar, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Aman U. Buzdar, MD/Professor ) |
| Study ID Numbers: | ID99-146 |
| Study First Received: | May 30, 2002 |
| Last Updated: | October 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00038402 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Cancer Non-Inflammatory Breast Cancer Operable Breast Cancer Herceptin Taxol FEC |
Fluorouracil Cyclophosphamide Epirubicin Trastuzumab Paclitaxel Neosar |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Trastuzumab Alkylating Agents Breast Diseases Skin Diseases |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Epirubicin Pharmacologic Actions Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
