Doxil
DrugDoxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
NCT Number: NCT00608972
The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer. The type of breast cancer being studied is negative for a protein called HER2/neu and for estrogen receptors (ER) and progesterone receptors (PR). HER2/neu, ER and PR are part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types.This study is being conducted for the following research purposes:· To find out what effects, if any, the study drug has on metastatic breast cancer. For instance, will the study drug cause the tumor(s) to shrink or stop growing?· To test the safety of the study drugs and to see what affects it has. For instance, are there any side effects? If so, what kind of side effects does the study drug cause? How severe are the side effects, and how often do they occur?· To see if the study drugs have any effect on keeping the disease from getting worse.
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Notify Me18 year and older
Female
Interventional
Phase 2
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Doxil 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Carboplatin 30 mg/m2 will be administered on Day 1 of each 28-day cycle.
Bevacizumab 10 mg/kg will be administered on Day 1 immediately following chemotherapy and alone on Day 15 of each 28-day cycle.
Other names: Avastin
Time frame: Two Years
Time frame: up to two years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: one year
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From date of randomization up to two years
median overall survival
Time frame: six months
Six-month survival rate
Rutgers, The State University of New Jersey
Other
A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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