Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203502
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2005-09-12
Brief Title:
Primary Systemic Therapy in OperableLocally Advanced Breast Cancer
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Primary Systemic Therapy Using Sequential DocetaxelCyclophosphamideBevacizumab Followed by Doxorubicin in OperableLocally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-05
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 main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin Twenty-eight to fifty-six days after undergoing surgery all patients will receive nine three-weekly infusions of bevacizumab
Detailed Description:
Prior to being enrolled in this study they will undergo an evaluation to determine eligibility The study doctor will obtain a complete medical history complete a physical examination including blood pressure and heart rate The doctor will also obtain a baseline ECG as well as blood tests approximately two tablespoons of blood In order to decrease the effects of food exercise and the sleepwake cycle variability all blood samples must be taken between 8AM - 10AM and patients will need to fast no food or drink for 10 hours prior to the blood test Patients will also need to strain from working out prior to the blood test The study will ask for a list of current medications Patients will not be eligible if they have a history of or now require long-term anticoagulant blood thinner therapy ie Coumadin or anything patients may be taking to prevent blood clots have an allergy to bevacizumab or any other drugs used in the study
Many of the following evaluations are commonly done to determine diagnosis andor stage of breast cancer and may have already had some of all of them done If the following procedures were not done within three weeks they will need to be done again prior to receiving any study therapy
Diagnosis of breast cancer by fine needle aspiration or core needle biopsy will be required for entry in this study
Clip Placement - a clip will be placed in the tumor during the core biopsies as a marker to assist surgeons at the time of surgery
Tumor Clip Placements - a caliper is similar to a ruler and is used to measure the tumor from the outside of the body instead of always having to use an ultrasound or MRI
Tumor Ultrasound - this is a non-invasive exam that uses sound waves to produce a picture of your tumor
All study participants will be treated with bevacizumab 15 mgkg plus docetaxel 75 mgm2 and cyclophosphamide 500 mgm2 every three weeks for a total of four treatments Three weeks after the completion of this part of the treatment patients will start receiving doxorubicin 60 mgm2 every three weeks for a total of four treatments All these drugs will be given as intravenous infusion on the first day of each three-week period
Patients will come in for every three week visits and have a physical exam including blood pressure and heart rate Medications lists will be taken and any side effects that may have been experienced Tumor caliper measurements will be done and blood will be drawn at each of these visits
A mammogram and MUGA scan will be done again just prior to surgery Patients will undergo tumor surgery approximately six months after treatment Patients will need to visit the study physician one month after surgery for another physical examination including blood pressure and heart rate an assessment of any side effects and a list of current medications
Many of the following evaluations are commonly done to determine diagnosis andor stage of breast cancer and may have already had some of all of them done If the following procedures were not done within three weeks they will need to be done again prior to receiving any study therapy
Diagnosis of breast cancer by fine needle aspiration or core needle biopsy will be required for entry in this study
Clip Placement - a clip will be placed in the tumor during the core biopsies as a marker to assist surgeons at the time of surgery
Tumor Clip Placements - a caliper is similar to a ruler and is used to measure the tumor from the outside of the body instead of always having to use an ultrasound or MRI
Tumor Ultrasound - this is a non-invasive exam that uses sound waves to produce a picture of your tumor
All study participants will be treated with bevacizumab 15 mgkg plus docetaxel 75 mgm2 and cyclophosphamide 500 mgm2 every three weeks for a total of four treatments Three weeks after the completion of this part of the treatment patients will start receiving doxorubicin 60 mgm2 every three weeks for a total of four treatments All these drugs will be given as intravenous infusion on the first day of each three-week period
Patients will come in for every three week visits and have a physical exam including blood pressure and heart rate Medications lists will be taken and any side effects that may have been experienced Tumor caliper measurements will be done and blood will be drawn at each of these visits
A mammogram and MUGA scan will be done again just prior to surgery Patients will undergo tumor surgery approximately six months after treatment Patients will need to visit the study physician one month after surgery for another physical examination including blood pressure and heart rate an assessment of any side effects and a list of current medications
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