Breast Cancer
Conditions
Keywords
Metastatic breast cancer
Brief summary
The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.
Detailed description
All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once every three weeks. This drug prevents tumor cells from dividing, so they may stop growing or die.
Interventions
DRUGXRP9881
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible for this trial you must: * Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery. * Have received previous treatment with anthracyclines (e.g. doxorubicin \[Adriamycin or Doxil\] or epirubicin \[Ellence\]), taxanes (paclitaxel \[Taxol or Abraxane\] or docetaxel \[Taxotere\]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments are no longer of benefit to you. * Be at least 18 years of age * Not be taking other treatments for your cancer at the time you enter the trial. * Not be pregnant * Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (lab tests, CT scans).
Exclusion criteria
* None listed here. Can be discussed with your doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks | — |
| Time to tumor response and duration of response. | — |
| Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs. | — |
Countries
Argentina, Belgium, Canada, Colombia, Denmark, France, Germany, Italy, Netherlands, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), United States
Outcome results
None listed