Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01670500
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2012-08-16
Brief Title:
Cisplatin vs DoxorubicinCyclophosphamide in BrCa
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Phase II Trial of Neoadjuvant Cisplatin vs DoxorubicinCyclophosphamide AC in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This research study is a Phase II clinical trial Phase II clinical trials test the effectiveness of an investigational drug which is cisplatin in this trial to learn how well it works in treating a specific cancer Investigational means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case how effective cisplatin is for treating breast cancer in BRCA mutation carriers It also means that the FDA has not yet approved cisplatin for your type of cancer Cisplatin has been approved by the FDA for treatment of other cancers
The purpose of this study is to evaluate cisplatin a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation In this study we are comparing cisplatin to the standard chemotherapy doxorubicin and cyclophosphamide AC that you might receive if you did not participate in this study
The purpose of this study is to evaluate cisplatin a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation In this study we are comparing cisplatin to the standard chemotherapy doxorubicin and cyclophosphamide AC that you might receive if you did not participate in this study
Detailed Description:
If screening tests show that you are eligible to participate in the research study you will begin study treatment You may undergo an optional research biopsy so the study team can obtain tissue samples This will be used for biomarker research and will help your doctors to better understand your disease how the drug is working in your body and may help to identify which people may benefit most from platinum or from adriamycincytoxan in the future
Because no one knows which of the study options is best you will be randomized to receive either cisplatin or doxorubicin and cyclophosphamide AC chemotherapy prior to removal of your breast cancer Chemotherapy administered before the removal of the cancer is known as neoadjuvant chemotherapy Randomization means that you are put into a group by chance It is like flipping a coin Neither you nor the research doctor will choose what group you will be in You will have an equal chance of being placed in either group
If you are randomized to receive cisplatin you will receive cisplatin once every three weeks for a total of four doses You will be given cisplatin by vein IV on the first day of each treatment cycle The cisplatin infusion can take between 1 to 2 hours Before and after receiving cisplatin you will receive fluid hydration by vein and you will also be given medicine to help prevent side effects such as nausea The total time of the infusion of cisplatin and the additional fluid and medications will take about 6 hours After you receive cisplatin you will be asked to drink about 12 eight ounce glasses of fluid per day especially 2 or 3 days after therapy The study treatment will stop if you have serious side effects or if the tumor grows despite receiving cisplatin chemotherapy
If you are randomized to AC chemotherapy you will receive both doxorubicin and cyclophosphamide once every 2 or 3 weeks for a total of four doses by vein on the first day of each treatment cycle The interval between chemotherapy will be decided by your research doctor If you receive the chemotherapy every two weeks you will also receive a subcutaneous injection the day after chemotherapy This injection contains a medicine that contains a growth factor that will boost your immune system in order to allow your body to be ready for chemotherapy in two weeks The study treatment will be stopped if you have serious side effects or if the tumor grows despite the doxorubicin and cyclophosphamide chemotherapy
At the beginning of each treatment cycle you will have a physical exam including weight and vital signs and you will be asked general questions about your health and any medications you may be taking as well as specific questions about any side effects you may be experiencing while receiving study treatment Prior to each cycle of chemotherapy you will have standard blood tests to check your blood counts If you are receiving cisplatin your kidney function and body salts will also be checked prior to each chemotherapy cycle In addition 7-10 days after chemotherapy your blood will be drawn to look at your blood cell count to determine your risk of infection if you have received cisplatin your kidney function and blood electrolytes will also be evaluated The blood draw performed 7-10 days after chemotherapy can be done in the hospital where you received your chemotherapy or closer to home About 1 tablespoon of blood will be drawn for these tests
Surgery to remove your tumor will occur within six weeks after the last dose of chemotherapy Your surgery will be performed by your surgeon as part of the standard care for your disease
Your treating physician or nurse practitioner will examine you to assess your tumor each time you receive chemotherapy A measurement of your tumor will be performed on the first day of each treatment cycle as part of your physical exam After the slides of your initial breast cancer biopsy have been reviewed at your hospital these slides and your tumor block will be sent to the study pathologist at DFHCC Likewise after chemotherapy your breast cancer will be removed by lumpectomy or mastectomy After these slides are reviewed at your hospital they will also be sent with the tumor block to the study pathologist so that the response of your tumor to the study treatment can be assessed After these slides are reviewed they will be returned to the hospital at which the biopsy and surgery were performed
Decisions about whether you will receive more chemotherapy after your surgery is up to your treating physicians If you receive chemotherapy the choice of chemotherapy is also up to your doctors Decisions about post-operative chemotherapy are not part of this study
Because no one knows which of the study options is best you will be randomized to receive either cisplatin or doxorubicin and cyclophosphamide AC chemotherapy prior to removal of your breast cancer Chemotherapy administered before the removal of the cancer is known as neoadjuvant chemotherapy Randomization means that you are put into a group by chance It is like flipping a coin Neither you nor the research doctor will choose what group you will be in You will have an equal chance of being placed in either group
If you are randomized to receive cisplatin you will receive cisplatin once every three weeks for a total of four doses You will be given cisplatin by vein IV on the first day of each treatment cycle The cisplatin infusion can take between 1 to 2 hours Before and after receiving cisplatin you will receive fluid hydration by vein and you will also be given medicine to help prevent side effects such as nausea The total time of the infusion of cisplatin and the additional fluid and medications will take about 6 hours After you receive cisplatin you will be asked to drink about 12 eight ounce glasses of fluid per day especially 2 or 3 days after therapy The study treatment will stop if you have serious side effects or if the tumor grows despite receiving cisplatin chemotherapy
If you are randomized to AC chemotherapy you will receive both doxorubicin and cyclophosphamide once every 2 or 3 weeks for a total of four doses by vein on the first day of each treatment cycle The interval between chemotherapy will be decided by your research doctor If you receive the chemotherapy every two weeks you will also receive a subcutaneous injection the day after chemotherapy This injection contains a medicine that contains a growth factor that will boost your immune system in order to allow your body to be ready for chemotherapy in two weeks The study treatment will be stopped if you have serious side effects or if the tumor grows despite the doxorubicin and cyclophosphamide chemotherapy
At the beginning of each treatment cycle you will have a physical exam including weight and vital signs and you will be asked general questions about your health and any medications you may be taking as well as specific questions about any side effects you may be experiencing while receiving study treatment Prior to each cycle of chemotherapy you will have standard blood tests to check your blood counts If you are receiving cisplatin your kidney function and body salts will also be checked prior to each chemotherapy cycle In addition 7-10 days after chemotherapy your blood will be drawn to look at your blood cell count to determine your risk of infection if you have received cisplatin your kidney function and blood electrolytes will also be evaluated The blood draw performed 7-10 days after chemotherapy can be done in the hospital where you received your chemotherapy or closer to home About 1 tablespoon of blood will be drawn for these tests
Surgery to remove your tumor will occur within six weeks after the last dose of chemotherapy Your surgery will be performed by your surgeon as part of the standard care for your disease
Your treating physician or nurse practitioner will examine you to assess your tumor each time you receive chemotherapy A measurement of your tumor will be performed on the first day of each treatment cycle as part of your physical exam After the slides of your initial breast cancer biopsy have been reviewed at your hospital these slides and your tumor block will be sent to the study pathologist at DFHCC Likewise after chemotherapy your breast cancer will be removed by lumpectomy or mastectomy After these slides are reviewed at your hospital they will also be sent with the tumor block to the study pathologist so that the response of your tumor to the study treatment can be assessed After these slides are reviewed they will be returned to the hospital at which the biopsy and surgery were performed
Decisions about whether you will receive more chemotherapy after your surgery is up to your treating physicians If you receive chemotherapy the choice of chemotherapy is also up to your doctors Decisions about post-operative chemotherapy are not part of this study
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