Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038402
Status:
COMPLETED
Last Update Posted:
2012-07-20
First Post:
2002-05-30
Brief Title:
Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 andor 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 MD Anderson Cancer Center outpatient clinic
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 andor 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 MD Anderson Cancer Center outpatient clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None